FDA 510(k) Application Details - K200264

Device Classification Name	Tissue Adhesive For The Topical Approximation Of Skin   More FDA Info for this Device
510(K) Number	K200264
Device Name	Tissue Adhesive For The Topical Approximation Of Skin
Applicant	Chemence Medical, Inc. 200 Technology Drive Alpharetta, GA 30005 US Other 510(k) Applications for this Company
Contact	Charnelle Thomas 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	02/03/2020
Decision Date	12/17/2020
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