The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Pms Ophthalmology Pack-pms Eye Tray/pack.
| Device ID | K850050 |
| 510k Number | K850050 |
| Device Name: | PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK |
| Classification | Sponge, Ophthalmic |
| Applicant | PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
| Contact | James E Williams |
| Correspondent | James E Williams PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-08 |
| Decision Date | 1985-04-23 |