FDA 510(k) Application Details - K964057

Device Classification Name Pack, Hot Or Cold, Water Circulating

  More FDA Info for this Device
510(K) Number K964057
Device Name Pack, Hot Or Cold, Water Circulating
Applicant HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE, IL 60048 US
Other 510(k) Applications for this Company
Contact JOSEPH S TOKARZ
Other 510(k) Applications for this Contact
Regulation Number 890.5720

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

  More FDA Info for this Product Code
Date Received 10/09/1996
Decision Date 12/31/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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