510(k) K131373

SHANGRING by Wuhu Snnda Medical Treatment Appliance Technology — Product Code HFX

K131373 is an FDA 510(k) premarket notification submitted by Wuhu Snnda Medical Treatment Appliance Technology for the device "SHANGRING". The FDA issued a decision of Substantially Equivalent on June 25, 2013. 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
June 25, 2013
Date Received
May 13, 2013
Clearance Type
Special
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