The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Pharmaseal Scrub Care-surgical Scrub Brush Sponges.
| Device ID | K854232 |
| 510k Number | K854232 |
| Device Name: | PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES |
| Classification | Brush, Scrub, Operating-room |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Contact | Lawrence Getlin |
| Correspondent | Lawrence Getlin AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Product Code | GEC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-21 |
| Decision Date | 1985-12-10 |