510(k) K760550
K760550 is an FDA 510(k) premarket notification submitted by Medical Instrument Research Assoc., Inc. for the device "IMPLANT, SILICONE AND TANTALUM". The FDA issued a decision of Substantially Equivalent on October 5, 1976. The device falls under product code HQJ (Implant, Absorbable, (Scleral Buckling Methods)), a Class II device regulated under 21 CFR 886.3300. Medical Instrument Research Assoc., Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 1976
- Date Received
- August 30, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Absorbable, (Scleral Buckling Methods)
- Device Class
- Class II
- Regulation Number
- 886.3300
- Review Panel
- OP
- Submission Type