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FDA 510(k) Application Details - K072085
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K072085
Device Name
Vinyl Patient Examination Glove
Applicant
ZIBO HONGYE SHANGQIN PLASTIC RUBBERT CO LTD
RM 1606 BLDG.1. JIANXIANG YUAN
NO 209 BEI SI HUAN ZHONG ROA
BEIJING 10083 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
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More FDA Info for this Product Code
Date Received
07/30/2007
Decision Date
09/04/2007
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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