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Innolitics
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Review Panel
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Review Panel
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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
FPX
Strip, Adhesive, Closure, Skin
1
Product Code
FPY
Sheet, Burn
1
Product Code
K
93
0759
CP & S STERILE BURN SHEET
1
Cleared 510(K)
K
92
6290
BURN SHEET
1
Cleared 510(K)
K
92
1471
BURNSHIELD TRAUMA DRESSING
1
Cleared 510(K)
K
92
1470
BURNSHIELD FIRE BLANKET
1
Cleared 510(K)
K
90
0443
BURNS CASUALTY SHEET LIMB WRAP
1
Cleared 510(K)
K
90
0442
BURNS CASUALTY SHEET BURN ROLL
1
Cleared 510(K)
K
90
0441
BURNS CASUALTY SHEET
1
Cleared 510(K)
K
87
1740
LYOSHEET SURGICAL SHEET FOR BURNS
1
Cleared 510(K)
K
85
3145
KENDALL CURITY BURN PAD
1
Cleared 510(K)
K
84
1898
FIRST RESPONSE EMERG. MEDICSL - BURNS
1
Cleared 510(K)
K
82
0994
ABSORB FURN SHEET
1
Cleared 510(K)
K
80
0064
WATER JEL FIRE BLANKET
1
Cleared 510(K)
K
79
2433
TEMPORARY BURN SHEET WITH PERFORATED
1
Cleared 510(K)
K
79
2432
TEMPORARY BURN SHEET WITH PERFORATED
1
Cleared 510(K)
K
78
0418
BURN DRESSING PAD
1
Cleared 510(K)
K
76
0365
BLANKET, BURN
1
Cleared 510(K)
K
76
0210
BLANKET, WATER-JEL FIRE
1
Cleared 510(K)
KGX
Tape And Bandage, Adhesive
1
Product Code
KMF
Bandage, Liquid
1
Product Code
LRS
I.V. Start Kit
2
Product Code
MCY
Wound Dressing Kit
2
Product Code
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
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
FPY
/
K792432
View Source
TEMPORARY BURN SHEET WITH PERFORATED
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K792432
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL DISPOSABLE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/20/1979
Days to Decision
22 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
FPX
Strip, Adhesive, Closure, Skin
FPY
Sheet, Burn
K
93
0759
CP & S STERILE BURN SHEET
K
92
6290
BURN SHEET
K
92
1471
BURNSHIELD TRAUMA DRESSING
K
92
1470
BURNSHIELD FIRE BLANKET
K
90
0443
BURNS CASUALTY SHEET LIMB WRAP
K
90
0442
BURNS CASUALTY SHEET BURN ROLL
K
90
0441
BURNS CASUALTY SHEET
K
87
1740
LYOSHEET SURGICAL SHEET FOR BURNS
K
85
3145
KENDALL CURITY BURN PAD
K
84
1898
FIRST RESPONSE EMERG. MEDICSL - BURNS
K
82
0994
ABSORB FURN SHEET
K
80
0064
WATER JEL FIRE BLANKET
K
79
2433
TEMPORARY BURN SHEET WITH PERFORATED
K
79
2432
TEMPORARY BURN SHEET WITH PERFORATED
K
78
0418
BURN DRESSING PAD
K
76
0365
BLANKET, BURN
K
76
0210
BLANKET, WATER-JEL FIRE
KGX
Tape And Bandage, Adhesive
KMF
Bandage, Liquid
LRS
I.V. Start Kit
MCY
Wound Dressing Kit
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
/
FPY
/
K792432
View Source
TEMPORARY BURN SHEET WITH PERFORATED
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K792432
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL DISPOSABLE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/20/1979
Days to Decision
22 days