FDA 510(k) Application Details - K061227

Device Classification Name Dressing, Wound, Drug

  More FDA Info for this Device
510(K) Number K061227
Device Name Dressing, Wound, Drug
Applicant THE HYMED GROUP CORP.
1890 BUCKNELL DR.
BETHLEHEM, PA 18015 US
Other 510(k) Applications for this Company
Contact ANITA PETITO
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 05/02/2006
Decision Date 12/20/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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