The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Pharmaseal Eye Prep Tray.
| Device ID | K850119 |
| 510k Number | K850119 |
| Device Name: | PHARMASEAL EYE PREP TRAY |
| Classification | Forceps, Ophthalmic |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 1015 GRANDVIEW P.O. BOX 1300 Glendale, CA 91209 |
| Contact | Larry W Getlin |
| Correspondent | Larry W Getlin AMERICAN PHARMASEAL DIV. AHSC 1015 GRANDVIEW P.O. BOX 1300 Glendale, CA 91209 |
| Product Code | HNR |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-05-09 |