The following data is part of a premarket notification filed by Kli with the FDA for Insufflator, Model G100 & 200.
Device ID | K772297 |
510k Number | K772297 |
Device Name: | INSUFFLATOR, MODEL G100 & 200 |
Classification | Insufflator, Laparoscopic |
Applicant | KLI 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HIF |
CFR Regulation Number | 884.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-13 |
Decision Date | 1978-01-05 |