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FDA 510(k) Application Details - K112743
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K112743
Device Name
Vinyl Patient Examination Glove
Applicant
CLEAN MEDICAL MANFACTURING CO;LTD
18633 E. GALE AVE.#105
CITY OF INDUSTRY, CA 91748 US
Other 510(k) Applications for this Company
Contact
AARON RICHARD
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
09/21/2011
Decision Date
12/16/2011
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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