The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Proximal Femoral Replacement Prosthesis.
Device ID | K874575 |
510k Number | K874575 |
Device Name: | PROXIMAL FEMORAL REPLACEMENT PROSTHESIS |
Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Lipscomb, Phd |
Correspondent | Lipscomb, Phd DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | JDG |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-06 |
Decision Date | 1988-01-07 |