FDA 510(k) Application Details - K141326

Device Classification Name Arthroscope

  More FDA Info for this Device
510(K) Number K141326
Device Name Arthroscope
Applicant BIOVISION TECHNOLOGIES, LLC
221 CORPORATE CIRCLE
SUITE H
GOLDEN, CO 80401 US
Other 510(k) Applications for this Company
Regulation Number 888.1100

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

  More FDA Info for this Product Code
Date Received 05/21/2014
Decision Date 10/08/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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