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FDA 510(k) Application Details - K082479
Device Classification Name
Gown, Surgical
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510(K) Number
K082479
Device Name
Gown, Surgical
Applicant
SKLAR CORP.
55 Northern Blvd
Suite 200
Great Neck, NY 11021 US
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NATALYA VALERIO
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Regulation Number
878.4040
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Classification Product Code
FYA
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Date Received
08/28/2008
Decision Date
04/24/2009
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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