The following data is part of a premarket notification filed by Kli with the FDA for Probe, Coagulation Accessory.
Device ID | K772220 |
510k Number | K772220 |
Device Name: | PROBE, COAGULATION ACCESSORY |
Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
Applicant | KLI 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KNF |
CFR Regulation Number | 884.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-05 |
Decision Date | 1977-12-13 |