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FDA 510(k) Application Details - K101276
Device Classification Name
Tissue Adhesive For The Topical Approximation Of Skin
More FDA Info for this Device
510(K) Number
K101276
Device Name
Tissue Adhesive For The Topical Approximation Of Skin
Applicant
CHEMENCE MEDICAL PRODUCTS INC.
185 BLUEGRASS VALLEY PARKWAY
SUITE 100
ALPHARETTA, GA 30005-2222 US
Other 510(k) Applications for this Company
Contact
PATRICIA LEHMAN
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
05/06/2010
Decision Date
07/28/2010
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
FDA Source Information for K101276
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