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 |