510(k) K121789

SHANGRING by Wuhu Snna Medical Treatment Appliance Technology C — Product Code HFX

K121789 is an FDA 510(k) premarket notification submitted by Wuhu Snna Medical Treatment Appliance Technology C for the device "SHANGRING". The FDA issued a decision of Substantially Equivalent on August 3, 2012. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2012
Date Received
June 19, 2012
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