510(k) K092984

PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 by Panpac Medical Corporation — Product Code LKF

K092984 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0". The FDA issued a decision of Substantially Equivalent on April 7, 2010. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Panpac Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2010
Date Received
September 28, 2009
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