The following data is part of a premarket notification filed by Ivalon with the FDA for Ivalon External Sponge.
| Device ID | K946015 |
| 510k Number | K946015 |
| Device Name: | IVALON EXTERNAL SPONGE |
| Classification | Gauze / Sponge,nonresorbable For External Use |
| 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 | NAB |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-09 |
| Decision Date | 1995-02-27 |