The following data is part of a premarket notification filed by Medmetric Corp. with the FDA for Kt1000/s Knee Ligament Arthrometer.
Device ID | K943197 |
510k Number | K943197 |
Device Name: | KT1000/S KNEE LIGAMENT ARTHROMETER |
Classification | Arthrometer |
Applicant | MEDMETRIC CORP. 7542 TRADE ST. San Diego, CA 92121 -2412 |
Contact | K.r. Watkins |
Correspondent | K.r. Watkins MEDMETRIC CORP. 7542 TRADE ST. San Diego, CA 92121 -2412 |
Product Code | LYH |
CFR Regulation Number | 890.1615 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-05 |
Decision Date | 1995-03-02 |