The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Schurman/carter Ii Hip Prosthesis, Porous Coated.
Device ID | K874939 |
510k Number | K874939 |
Device Name: | SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED |
Classification | Blood Pressure Cuff |
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 | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-02 |
Decision Date | 1988-02-02 |