The following data is part of a premarket notification filed by Mayo Clinic with the FDA for Mayo Hip Prosthesis.
Device ID | K943230 |
510k Number | K943230 |
Device Name: | MAYO HIP PROSTHESIS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | Mayo Clinic 200 FIRST ST. SW Rochester, MN 55902 |
Contact | B. F Morrey |
Correspondent | B. F Morrey Mayo Clinic 200 FIRST ST. SW Rochester, MN 55902 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-06 |
Decision Date | 1997-01-14 |
Summary: | summary |