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FDA 510(k) Application Details - K210131
Device Classification Name
Gown, Isolation, Surgical
More FDA Info for this Device
510(K) Number
K210131
Device Name
Gown, Isolation, Surgical
Applicant
GRI-Alleset, Inc
4142 Industry Way
Flowery Branch, GA 30542 US
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Contact
Marty D Paugh
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
FYC
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More FDA Info for this Product Code
Date Received
01/19/2021
Decision Date
08/26/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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