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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
NGU
Balloon, Liver Tamponade
2
Product Code
EYR
Tourniquet, Gastro-Urology
1
Product Code
EXM
Truss, Umbilical
1
Product Code
EYN
Tray, Irrigation, Sterile
2
Product Code
FBQ
Trocar, Gastro-Urology
2
Product Code
FZG
Apparatus, Air Handling, Bench
2
Product Code
FZH
Apparatus, Air Handling, Room
2
Product Code
FZI
Apparatus, Air Handling, Enclosure
2
Product Code
GAX
Tourniquet, Nonpneumatic
1
Product Code
K
93
1198
UNIQUET
1
Cleared 510(K)
K
88
1398
TOURNIQUET
1
Cleared 510(K)
K
88
1176
STERILE ESMARCH BANDAGE
1
Cleared 510(K)
K
87
5092
DEGANIA SILICONE TOURNIQUET
1
Cleared 510(K)
K
87
3928
UNIVERSAL TOURNIQUET
1
Cleared 510(K)
K
87
2003
KINDERWRAP
1
Cleared 510(K)
K
86
4897
DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
1
Cleared 510(K)
K
85
3472
FINGER TOURNIQUETTE
1
Cleared 510(K)
K
85
3537
VELCRO TOURNIQUET
1
Cleared 510(K)
K
85
2277
CATAPRESS TOURNIGUET
1
Cleared 510(K)
K
85
1482
TOURNIQUET
1
Cleared 510(K)
K
84
3056
ELASTIC BANDAGE
1
Cleared 510(K)
K
84
0489
DISPOSIQUET A DISPOS. TOURNIQUET
1
Cleared 510(K)
K
83
0467
TOURNIQUET/LATEX TOURNIQUET
1
Cleared 510(K)
K
82
2553
PRESSURE-QUET TOURNIQUET
1
Cleared 510(K)
K
82
1700
LATEX PENROSE DRAIN TUBING
1
Cleared 510(K)
K
80
3142
CONPHAR VELCRO TOUNIGUER
1
Cleared 510(K)
K
79
0802
ESSAR TOURNIQUET FOR VENIPUNCTURE
1
Cleared 510(K)
K
78
0594
VELKET TOURNIQUET
1
Cleared 510(K)
K
78
0429
TOURNEQUET, NON-PNEUMATIC
1
Cleared 510(K)
KCW
Epilator, High Frequency, Needle-Type
1
Product Code
KCX
Epilator, High Frequency, Tweezer-Type
1
Product Code
KCY
Tourniquet, Pneumatic
1
Product Code
KPJ
Chamber, Oxygen, Topical, Extremity
2
Product Code
OJS
Tourniquet Kit
1
Product Code
OLI
Fat Reducing Low Level Laser
2
Product Code
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
2
Product Code
QGX
General Use Pneumatic Tourniquet
1
Product Code
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 20 December 2024 at 11:05 pm
SU
/
subpart-f—therapeutic-devices
/
GAX
/
K840489
View Source
DISPOSIQUET A DISPOS. TOURNIQUET
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K840489
510(k) Type
Traditional
Applicant
MED LAB PRODUCTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/12/1984
Days to Decision
35 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
NGU
Balloon, Liver Tamponade
EYR
Tourniquet, Gastro-Urology
EXM
Truss, Umbilical
EYN
Tray, Irrigation, Sterile
FBQ
Trocar, Gastro-Urology
FZG
Apparatus, Air Handling, Bench
FZH
Apparatus, Air Handling, Room
FZI
Apparatus, Air Handling, Enclosure
GAX
Tourniquet, Nonpneumatic
K
93
1198
UNIQUET
K
88
1398
TOURNIQUET
K
88
1176
STERILE ESMARCH BANDAGE
K
87
5092
DEGANIA SILICONE TOURNIQUET
K
87
3928
UNIVERSAL TOURNIQUET
K
87
2003
KINDERWRAP
K
86
4897
DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
K
85
3472
FINGER TOURNIQUETTE
K
85
3537
VELCRO TOURNIQUET
K
85
2277
CATAPRESS TOURNIGUET
K
85
1482
TOURNIQUET
K
84
3056
ELASTIC BANDAGE
K
84
0489
DISPOSIQUET A DISPOS. TOURNIQUET
K
83
0467
TOURNIQUET/LATEX TOURNIQUET
K
82
2553
PRESSURE-QUET TOURNIQUET
K
82
1700
LATEX PENROSE DRAIN TUBING
K
80
3142
CONPHAR VELCRO TOUNIGUER
K
79
0802
ESSAR TOURNIQUET FOR VENIPUNCTURE
K
78
0594
VELKET TOURNIQUET
K
78
0429
TOURNEQUET, NON-PNEUMATIC
KCW
Epilator, High Frequency, Needle-Type
KCX
Epilator, High Frequency, Tweezer-Type
KCY
Tourniquet, Pneumatic
KPJ
Chamber, Oxygen, Topical, Extremity
OJS
Tourniquet Kit
OLI
Fat Reducing Low Level Laser
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
QGX
General Use Pneumatic Tourniquet
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—therapeutic-devices
/
GAX
/
K840489
View Source
DISPOSIQUET A DISPOS. TOURNIQUET
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K840489
510(k) Type
Traditional
Applicant
MED LAB PRODUCTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/12/1984
Days to Decision
35 days