510(k) K771961

DUAL INCISION TUBAL OCCLUS. BAND APPLI. by Kli — Product Code HET

K771961 is an FDA 510(k) premarket notification submitted by Kli for the device "DUAL INCISION TUBAL OCCLUS. BAND APPLI.". The FDA issued a decision of Substantially Equivalent on October 25, 1977. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Kli has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1977
Date Received
October 17, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type