FDA 510(k) Application Details - K060878

Device Classification Name Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

  More FDA Info for this Device
510(K) Number K060878
Device Name Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Applicant CURAMEDICAL, BV
220 RIVER ROAD
CLAREMONT, NH 03743 US
Other 510(k) Applications for this Company
Contact WILLIAM GREENROSE
Other 510(k) Applications for this Contact
Regulation Number 874.3620

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

  More FDA Info for this Product Code
Date Received 03/31/2006
Decision Date 04/13/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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