510(k) K854861

SETMA HYGIA BATH MODEL ST 7200 by Setma, Inc. — Product Code ILJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1986
Date Received
December 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Hydro-Massage
Device Class
Class II
Regulation Number
890.5100
Review Panel
PM
Submission Type