510(k) K131373
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