FDA 510(k) Application Details - K970266

Device Classification Name Dressing, Wound, Collagen

  More FDA Info for this Device
510(K) Number K970266
Device Name Dressing, Wound, Collagen
Applicant KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
Other 510(k) Applications for this Company
Contact DAVID A OLSON
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 01/23/1997
Decision Date 04/23/1997
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee -
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