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FDA 510(k) Application Details - K100294
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K100294
Device Name
Vinyl Patient Examination Glove
Applicant
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD
12390 EAST END AVE.
CHINO, CA 91710 US
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Contact
FRANK LIU
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
02/02/2010
Decision Date
05/14/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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