The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Murray/welch Total Hip System.
Device ID | K871402 |
510k Number | K871402 |
Device Name: | MURRAY/WELCH TOTAL HIP SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
Contact | Sam Son |
Correspondent | Sam Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-08 |
Decision Date | 1987-07-16 |