FDA 510(k) Application Details - K960496

Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence

  More FDA Info for this Device
510(K) Number K960496
Device Name Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant UTAH MEDICAL PRODUCTS, INC.
7043 SOUTH 300 WEST
MIDVALE, UT 84047-1048 US
Other 510(k) Applications for this Company
Contact JOHN W SMITH
Other 510(k) Applications for this Contact
Regulation Number 876.5320

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

  More FDA Info for this Product Code
Date Received 02/01/1996
Decision Date 06/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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