FDA 510(k) Application Details - K212246

Device Classification Name	Tissue Adhesive For The Topical Approximation Of Skin   More FDA Info for this Device
510(K) Number	K212246
Device Name	Tissue Adhesive For The Topical Approximation Of Skin
Applicant	Chemence Medical, Inc. 200 Technology Drive Alpharetta, GA 30115 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	07/19/2021
Decision Date	09/09/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review