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FDA 510(k) Application Details - K081476
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K081476
Device Name
Drape, Surgical
Applicant
SURGICAL CONCEPT DESIGNS
307 PROSPECT AVENUE
SUITE 2G
HACKENSACK, NJ 07601 US
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Contact
CHRISTOPHER SCOTT
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
05/27/2008
Decision Date
08/08/2008
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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