The following data is part of a premarket notification filed by Kli with the FDA for Laparoscopy Console Model Viii.
Device ID | K772242 |
510k Number | K772242 |
Device Name: | LAPAROSCOPY CONSOLE MODEL VIII |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | KLI 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-08 |
Decision Date | 1977-12-20 |