510(k) K896817

MODEL T11 FLUIDOTHERAPY UNIT by Henley Intl. — Product Code LSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1991
Date Received
December 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Fluidotherapy
Device Class
Class II
Regulation Number
890.5100
Review Panel
PM
Submission Type