510(k) K842559

WHITESIDE ORTHOLOC TOTAL HIP FEMORAL by Dow Corning Corp. Healthcare Industries Materials — Product Code KWL

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