The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Ssa Hip Prosthesis.
Device ID | K840357 |
510k Number | K840357 |
Device Name: | SSA HIP PROSTHESIS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-26 |
Decision Date | 1984-02-17 |