The following data is part of a premarket notification filed by Stelkast Company with the FDA for Provident Hp System.
Device ID | K946371 |
510k Number | K946371 |
Device Name: | PROVIDENT HP SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | STELKAST COMPANY 800 VINIAL ST. SUITE B-210 Pittsburgh, PA 15212 |
Contact | Donald A Stevens |
Correspondent | Donald A Stevens STELKAST COMPANY 800 VINIAL ST. SUITE B-210 Pittsburgh, PA 15212 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-06 |
Decision Date | 1995-04-05 |