The following data is part of a premarket notification filed by Kli with the FDA for 8mm Trocar & Cannual W/stopcock.
Device ID | K771964 |
510k Number | K771964 |
Device Name: | 8MM TROCAR & CANNUAL W/STOPCOCK |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | KLI 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-17 |
Decision Date | 1977-10-25 |