510(k) K853916
K853916 is an FDA 510(k) premarket notification submitted by Advanced Biosearch Assn. for the device "P.M. HIP-FEMORAL PROSTHESIS". The FDA issued a decision of Substantially Equivalent on December 27, 1985. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Advanced Biosearch Assn. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 1985
- Date Received
- September 23, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device Class
- Class II
- Regulation Number
- 888.3350
- Review Panel
- OR
- Submission Type