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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
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Subpart D—Prosthetic Devices
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FPX
Strip, Adhesive, Closure, Skin
1
Product Code
FPY
Sheet, Burn
1
Product Code
KGX
Tape And Bandage, Adhesive
1
Product Code
KMF
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1
Product Code
LRS
I.V. Start Kit
2
Product Code
MCY
Wound Dressing Kit
2
Product Code
K
97
0721
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
2
Cleared 510(K)
K
96
3719
CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
2
Cleared 510(K)
K
96
0585
WOUND CARE COMPRESSION SYSTEM (WCCS)
2
Cleared 510(K)
K
95
2334
DRESSING CHANGE TRAY
2
Cleared 510(K)
K
95
1022
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2
Cleared 510(K)
K
95
1021
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2
Cleared 510(K)
K
95
1476
E-PACK PROCEDURE KITS
2
Cleared 510(K)
K
93
1932
DRESSING CHANGE TRAY-MODIFIED
2
Cleared 510(K)
K
92
4690
VARIOUS NON-STERILE CUSTOM TRAYS/KITS
2
Cleared 510(K)
K
92
3905
WOUND DRESSING KIT
2
Cleared 510(K)
Show All 24 Submissions
MHW
Dressing, Compression
1
Product Code
NEC
Bandage, Liquid, Skin Protectant
1
Product Code
OXQ
Dressing Change Tray
1
Product Code
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
1
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
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Medical Genetics
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Unknown
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Last synced on 30 November 2024 at 11:09 am
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
MCY
/
K951476
View Source
E-PACK PROCEDURE KITS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K951476
510(k) Type
Traditional
Applicant
ETHICON, INC.
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
5/23/1995
Days to Decision
54 days
Submission Type
Summary
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
FPX
Strip, Adhesive, Closure, Skin
FPY
Sheet, Burn
KGX
Tape And Bandage, Adhesive
KMF
Bandage, Liquid
LRS
I.V. Start Kit
MCY
Wound Dressing Kit
K
97
0721
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
K
96
3719
CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
K
96
0585
WOUND CARE COMPRESSION SYSTEM (WCCS)
K
95
2334
DRESSING CHANGE TRAY
K
95
1022
CIRCULON SYSTEM STEP 1
K
95
1021
CIRCULON SYSTEM STEP 2
K
95
1476
E-PACK PROCEDURE KITS
K
93
1932
DRESSING CHANGE TRAY-MODIFIED
K
92
4690
VARIOUS NON-STERILE CUSTOM TRAYS/KITS
K
92
3905
WOUND DRESSING KIT
Show All 24 Submissions
MHW
Dressing, Compression
NEC
Bandage, Liquid, Skin Protectant
OXQ
Dressing Change Tray
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
MCY
/
K951476
View Source
E-PACK PROCEDURE KITS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K951476
510(k) Type
Traditional
Applicant
ETHICON, INC.
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
5/23/1995
Days to Decision
54 days
Submission Type
Summary