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FDA 510(k) Application Details - K010711
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K010711
Device Name
Drape, Surgical
Applicant
ADVANCED SURGICAL CONCEPTS (ASC)
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact
MARY MCNAMARA-CULLINANE
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
KKX
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More FDA Info for this Product Code
Date Received
03/09/2001
Decision Date
05/22/2001
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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