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FDA 510(k) Application Details - K123133
Device Classification Name
Tissue Adhesive For The Topical Approximation Of Skin
More FDA Info for this Device
510(K) Number
K123133
Device Name
Tissue Adhesive For The Topical Approximation Of Skin
Applicant
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
WESTERN WOOD WAY
LANAGAGE SCIENCE PARK
PLYMOUTH PL7 5BG GB
Other 510(k) Applications for this Company
Contact
MICHAEL BROWNE
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
10/04/2012
Decision Date
05/22/2013
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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