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FDA 510(k) Application Details - K082822
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K082822
Device Name
Vinyl Patient Examination Glove
Applicant
ZIBO ZHUANGYUAN PLASTIC PRODUCTS COMPANY
RM.1606, BLDG.1,JIANXIANG YUAN
NO.209 BEI SI HUAN ZHONG RD
HAIDIAN DISTRICT, BEIJING 100083 CN
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Contact
CHU XIAOAN
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/25/2008
Decision Date
10/22/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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