FDA 510(k) Application Details - K022127

Device Classification Name Dressing, Wound, Collagen

  More FDA Info for this Device
510(K) Number K022127
Device Name Dressing, Wound, Collagen
Applicant INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536 US
Other 510(k) Applications for this Company
Contact JUDITH E O'GRADY
Other 510(k) Applications for this Contact
Regulation Number 000.0000

  More FDA Info for this Regulation Number
Classification Product Code KGN
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/01/2002
Decision Date 09/10/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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