The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Decubitus Care Absorbent Dressing.
Device ID | K832407 |
510k Number | K832407 |
Device Name: | DECUBITUS CARE ABSORBENT DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | AMERICAN PHARMASEAL DIV. AHSC 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-21 |
Decision Date | 1984-01-19 |