The following data is part of a premarket notification filed by Marwood Medical, Inc. with the FDA for Eye Procedure Pack.
| Device ID | K850340 |
| 510k Number | K850340 |
| Device Name: | EYE PROCEDURE PACK |
| Classification | Sponge, Ophthalmic |
| Applicant | MARWOOD MEDICAL, INC. BOX 8712 Greensboro, NC 27410 |
| Contact | Denise Ranck |
| Correspondent | Denise Ranck MARWOOD MEDICAL, INC. BOX 8712 Greensboro, NC 27410 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-28 |
| Decision Date | 1985-05-22 |