The following data is part of a premarket notification filed by Ivalon with the FDA for Ivalon Ophthalmic Sponge.
Device ID | K946016 |
510k Number | K946016 |
Device Name: | IVALON OPHTHALMIC SPONGE |
Classification | Sponge, Ophthalmic |
Applicant | IVALON 5374 LINDA VISTA RD., SUITE C San Diego, CA 92110 |
Contact | Elizabeth J Melaragno |
Correspondent | Elizabeth J Melaragno IVALON 5374 LINDA VISTA RD., SUITE C San Diego, CA 92110 |
Product Code | HOZ |
CFR Regulation Number | 886.4790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-09 |
Decision Date | 1995-03-22 |