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FDA 510(k) Application Details - K110724
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K110724
Device Name
Gown, Surgical
Applicant
OMNIA SPA
11460 N MERIDIAN STREET
SUITE 150
CARMEL, IN 46032 US
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Contact
JAMIE AUSTIN
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
FYA
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More FDA Info for this Product Code
Date Received
03/16/2011
Decision Date
06/23/2011
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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