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

DISPOSABLE ENDOMETRIAL SUCTION CURETTE

K Number: K102847 · Decision Apr 14, 2011
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
41
Applicant Total
2
Review Days
197

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Basic Information

Device Name
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
K Number
K102847
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
884.1175
Medical Specialty
Obstetrics/Gynecology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Jiangsu Suyun Medical Materials Co., Ltd.
Date Received
September 29, 2010
Decision Date
April 14, 2011
Product Code
HHK
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
HHK Curette, Suction, Endometrial (And Accessories)

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Other Clearances by Jiangsu Suyun Medical Materials Co., Ltd.

K Number Device Name
K202437 Infusion Sets for Single Use