The following data is part of a premarket notification filed by Katena Products, Inc. with the FDA for Instrument Wipe And Corneal Shield.
| Device ID | K912576 |
| 510k Number | K912576 |
| Device Name: | INSTRUMENT WIPE AND CORNEAL SHIELD |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | KATENA PRODUCTS, INC. 4 STEWART CT. Denville, NJ 07834 |
| Contact | Kate Tiedemann |
| Correspondent | Kate Tiedemann KATENA PRODUCTS, INC. 4 STEWART CT. Denville, NJ 07834 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-12 |
| Decision Date | 1992-01-31 |