FDA 510(k) Application Details - K952687

Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue

  More FDA Info for this Device
510(K) Number K952687
Device Name Fastener, Fixation, Biodegradable, Soft Tissue
Applicant ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE, NJ 08876 US
Other 510(k) Applications for this Company
Contact JOHN D PAULSON
Other 510(k) Applications for this Contact
Regulation Number 888.3030

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

  More FDA Info for this Product Code
Date Received 06/12/1995
Decision Date 02/06/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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