The following data is part of a premarket notification filed by Medical Instrument Research Assoc., Inc. with the FDA for Implant, Silicone And Tantalum.
| Device ID | K760550 |
| 510k Number | K760550 |
| Device Name: | IMPLANT, SILICONE AND TANTALUM |
| Classification | Implant, Absorbable, (scleral Buckling Methods) |
| Applicant | MEDICAL INSTRUMENT RESEARCH ASSOC., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQJ |
| CFR Regulation Number | 886.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-30 |
| Decision Date | 1976-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850510007457 | K760550 | 000 |
| 20850510007150 | K760550 | 000 |
| 20850510007068 | K760550 | 000 |