510(k) K063429

GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 by Generic Medical Device, Inc. — Product Code HFX

K063429 is an FDA 510(k) premarket notification submitted by Generic Medical Device, Inc. for the device "GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200". The FDA issued a decision of Substantially Equivalent on January 17, 2007. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Generic Medical Device, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2007
Date Received
November 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Circumcision
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type