The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Compression Hip Screw System.
Device ID | K850886 |
510k Number | K850886 |
Device Name: | COMPRESSION HIP SCREW SYSTEM |
Classification | Media And Components, Synthetic Cell And Tissue Culture |
Applicant | PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
Contact | Ronald Duchene |
Correspondent | Ronald Duchene PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
Product Code | KIT |
CFR Regulation Number | 864.2220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-04 |
Decision Date | 1985-04-19 |