510(k) K842559
K842559 is an FDA 510(k) premarket notification submitted by Dow Corning Corp. Healthcare Industries Materials for the device "WHITESIDE ORTHOLOC TOTAL HIP FEMORAL". The FDA issued a decision of Substantially Equivalent on December 20, 1984. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Dow Corning Corp. Healthcare Industries Materials has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 1984
- Date Received
- July 2, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type