The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Visoshield(tm), Surgical Eye Protector.
| Device ID | K894516 |
| 510k Number | K894516 |
| Device Name: | VISOSHIELD(TM), SURGICAL EYE PROTECTOR |
| Classification | Mask, Surgical |
| Applicant | POLAMEDCO, INC. 8295 S.LA CIENEGA BLVD. Inglewood, CA 90301 -1521 |
| Contact | Jackie Farrant |
| Correspondent | Jackie Farrant POLAMEDCO, INC. 8295 S.LA CIENEGA BLVD. Inglewood, CA 90301 -1521 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-19 |
| Decision Date | 1989-09-12 |