FDA 510(k) Application Details - K140517

Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin

  More FDA Info for this Device
510(K) Number K140517
Device Name Tissue Adhesive For The Topical Approximation Of Skin
Applicant Adhezion Biomedical, LLC
ONE MERIDIAN BLVD. SUITE 1B02
WYOMISSING, PA 19610 US
Other 510(k) Applications for this Company
Contact RICHARD JONES
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 02/28/2014
Decision Date 04/28/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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