The following data is part of a premarket notification filed by Medical Instrument Research Assoc., Inc. with the FDA for Soft Silicone Elastomer Sponge Explant.
| Device ID | K780987 |
| 510k Number | K780987 |
| Device Name: | SOFT SILICONE ELASTOMER SPONGE EXPLANT |
| Classification | Sponge, Ophthalmic |
| Applicant | MEDICAL INSTRUMENT RESEARCH ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-14 |
| Decision Date | 1978-09-28 |