FDA 510(k) Application Details - K010702

Device Classification Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat

  More FDA Info for this Device
510(K) Number K010702
Device Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant KMI KOLSTER METHODS, INC.
1170 N. GILBERT ST.
ANAHEIM, CA 92801 US
Other 510(k) Applications for this Company
Contact ALWIN H KOLSTER
Other 510(k) Applications for this Contact
Regulation Number 890.5300

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

  More FDA Info for this Product Code
Date Received 03/08/2001
Decision Date 08/09/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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