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510(k) K952442

FREEDOM BATH by Grand Traverse Technologies — Product Code ILJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1995
Date Received
May 25, 1995
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

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  • K991184 — HYDROTONE-THERMAL CAPSULE SYSTEM (June 23, 1999)