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FDA 510(k) Application Details - K141157
Device Classification Name
Tissue Adhesive For The Topical Approximation Of Skin
More FDA Info for this Device
510(K) Number
K141157
Device Name
Tissue Adhesive For The Topical Approximation Of Skin
Applicant
OPTMED, INC.
601 LEXINGTON AVENUE
SUITE 5100
NEW YORK, NY 10022 US
Other 510(k) Applications for this Company
Contact
STEPHANIE RAIS
Other 510(k) Applications for this Contact
Regulation Number
878.4010
More FDA Info for this Regulation Number
Classification Product Code
MPN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/05/2014
Decision Date
12/22/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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