The following data is part of a premarket notification filed by Medmetric Corp. with the FDA for Kt-1000 Device.
Device ID | K812806 |
510k Number | K812806 |
Device Name: | KT-1000 DEVICE |
Classification | Arthrometer |
Applicant | MEDMETRIC CORP. MD |
Product Code | LYH |
CFR Regulation Number | 890.1615 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-06 |
Decision Date | 1981-11-10 |