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FDA 510(k) Application Details - K071999
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K071999
Device Name
Vinyl Patient Examination Glove
Applicant
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD
ROOM 1606 BLDG. 1,
JIANZIANG YUAN NO 209 BEI SI
HUAN ZHONG, ROA; BEIJING 10008 CN
Other 510(k) Applications for this Company
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
07/23/2007
Decision Date
05/08/2008
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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