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FDA 510(k) Application Details - K101688
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K101688
Device Name
Drape, Surgical
Applicant
EXACT MEDICAL MANUFACTURING, INC
1083 DELAWARE AVE
BUFFALO, NY 14209 US
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Contact
ROBERT O DEAN
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
KKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2010
Decision Date
09/20/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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