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FDA 510(k) Application Details - K061422
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K061422
Device Name
Drape, Surgical
Applicant
AUSTIN MEDICAL, INC.
3460 POINTE CREEK CT.
#102
BONITA SPRINGS, FL 34134-2015 US
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Contact
PAUL DRYDEN
Other 510(k) Applications for this Contact
Regulation Number
878.4370
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Classification Product Code
KKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/23/2006
Decision Date
09/25/2006
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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