The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Amc R Metacarpal Component.
Device ID | K790793 |
510k Number | K790793 |
Device Name: | AMC R METACARPAL COMPONENT |
Classification | Prosthesis, Wrist, Carpal Lunate |
Applicant | HOWMEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KWN |
CFR Regulation Number | 888.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-24 |
Decision Date | 1979-06-22 |