FDA 510(k) Application Details - K982659

Device Classification Name Hysteroscope (And Accessories)

  More FDA Info for this Device
510(K) Number K982659
Device Name Hysteroscope (And Accessories)
Applicant MEDIVISION SCOPE SERVICE CENTER, INC.
1440 SOUTH STATE COLLEGE BLVD.
SUITE 1C
ANAHEIM, CA 92806 US
Other 510(k) Applications for this Company
Contact WAYNE B STERNER
Other 510(k) Applications for this Contact
Regulation Number 884.1690

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

  More FDA Info for this Product Code
Date Received 07/30/1998
Decision Date 10/07/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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