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FDA 510(k) Application Details - K052668
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K052668
Device Name
Drape, Surgical
Applicant
OR SPECIFIC, INC.
4651 36TH ST. #500
ORLANDO, FL 32811 US
Other 510(k) Applications for this Company
Contact
Daniel Becker
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
09/27/2005
Decision Date
07/24/2006
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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