FDA 510(k) Application Details - K003134

Device Classification Name Dressing, Wound, Collagen

  More FDA Info for this Device
510(K) Number K003134
Device Name Dressing, Wound, Collagen
Applicant ADRI/TECHNAM
P.O. BOX 134
PARK FOREST, IL 60466 US
Other 510(k) Applications for this Company
Contact GEORGE H SCHERR
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 10/06/2000
Decision Date 12/22/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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