FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

DECUBITUS CARE ABSORBENT DRESSING

K Number: K832407 · Decision Jan 19, 1984
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
64
Review Days
182

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Basic Information

Device Name
DECUBITUS CARE ABSORBENT DRESSING
K Number
K832407
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
American Pharmaseal Div. Ahsc
Date Received
July 21, 1983
Decision Date
January 19, 1984
Product Code
FRO
Advisory Committee
Unknown
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FRO Dressing, Wound, Drug

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Other Clearances by American Pharmaseal Div. Ahsc

K Number Device Name
K874022 PHARMASEAL WOUND IRRIGATION DEVICE
K874517 PHARMASEAL RUBBER URETHRAL CATHETER
K874045 PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
K873359 AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE
K872228 PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
K872917 JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
K871429 ANTIMICROBIAL FOLEY CATHETER
K871770 AMERICAN PHARMASEAL WOUND DRESSING
K870387 EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
K870977 PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
Search all 64 clearances from American Pharmaseal Div. Ahsc →