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FDA 510(k) Application Details - K050508
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K050508
Device Name
Drape, Surgical
Applicant
HAYWOOD VOCATIONAL OPPORTUNITIES
56 SCATES ST.
WAYNESVILLE, NC 28786 US
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Contact
TIM KELLEY
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
02/28/2005
Decision Date
04/27/2005
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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