FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

SHANGRING

K Number: K131373 · Decision Jun 25, 2013
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
1
Review Days
43

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Basic Information

Device Name
SHANGRING
K Number
K131373
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
884.4530
Medical Specialty
Obstetrics/Gynecology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Wuhu Snnda Medical Treatment Appliance Technology
Date Received
May 13, 2013
Decision Date
June 25, 2013
Product Code
HFX
Advisory Committee
Obstetrics/Gynecology
Review Advisory Committee
OB
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HFX Clamp, Circumcision

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