510(k) K963824

LI'S ITCH STOPPER by Hontech Foundation For Medical Technology — Product Code IRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1996
Date Received
September 23, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Heating, Powered
Device Class
Class II
Regulation Number
890.5740
Review Panel
PM
Submission Type