510(k) K963768

INSTANT HOT PACKS by Kick Ice, Inc. — Product Code IMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1996
Date Received
September 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Disposable
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type