FDA 510(k) Application Details - K152096

Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin

  More FDA Info for this Device
510(K) Number K152096
Device Name Tissue Adhesive For The Topical Approximation Of Skin
Applicant Ethicon, Inc.
Route 22 West, P.O. Box 151
Somerville, NJ 08876-0151 US
Other 510(k) Applications for this Company
Contact Donna Marshall
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 07/28/2015
Decision Date 10/22/2015
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact