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 |