The following data is part of a premarket notification filed by Kli with the FDA for Laparoscope W/removable Optics.
Device ID | K772185 |
510k Number | K772185 |
Device Name: | LAPAROSCOPE W/REMOVABLE OPTICS |
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 | 1977-11-25 |
Decision Date | 1977-11-30 |