The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for American Pharmaseal Wound Dressing.
Device ID | K871770 |
510k Number | K871770 |
Device Name: | AMERICAN PHARMASEAL WOUND DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
Contact | Robert T Merrick |
Correspondent | Robert T Merrick AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-06 |
Decision Date | 1987-06-26 |