510(k) K772230

CANNULA, PERFUSION, FALLOPIAN TUBE by J. Sklar Mfg. Co., Inc. — Product Code LKF

K772230 is an FDA 510(k) premarket notification submitted by J. Sklar Mfg. Co., Inc. for the device "CANNULA, PERFUSION, FALLOPIAN TUBE". The FDA issued a decision of Substantially Equivalent on January 3, 1978. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. J. Sklar Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1978
Date Received
December 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type