The following data is part of a premarket notification filed by Katena Products, Inc. with the FDA for K-sponge.
| Device ID | K897034 |
| 510k Number | K897034 |
| Device Name: | K-SPONGE |
| Classification | Sponge, Ophthalmic |
| 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 | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-18 |
| Decision Date | 1990-02-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() K-SPONGE 74008556 1640919 Live/Registered |
KATENA PRODUCTS, INC. 1989-12-07 |