FDA 510(k) Application Details - K230981

Device Classification Name	Tissue Adhesive For The Topical Approximation Of Skin   More FDA Info for this Device
510(K) Number	K230981
Device Name	Tissue Adhesive For The Topical Approximation Of Skin
Applicant	M/s Meril Endo Surgery Private Limited Third Floor, E1-E3, Meril Park Survey No. 135/2B & 174/2 Muktanand Marg Chala, Vapi 396191 IN Other 510(k) Applications for this Company
Contact	Umesh Sharma 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	04/05/2023
Decision Date	03/16/2024
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