The following data is part of a premarket notification filed by Kli with the FDA for Single Incision Tubal Occlu. Band Appl..
Device ID | K771963 |
510k Number | K771963 |
Device Name: | SINGLE INCISION TUBAL OCCLU. BAND APPL. |
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 | 1977-10-17 |
Decision Date | 1977-10-25 |