The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Parke-davis Total Hip Prosthesis.
Device ID | K791875 |
510k Number | K791875 |
Device Name: | PARKE-DAVIS TOTAL HIP PROSTHESIS |
Classification | Blood Pressure Cuff |
Applicant | WARNER-LAMBERT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-21 |
Decision Date | 1979-10-04 |