510(k) K971592

XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM by The Silcraft Corp. — Product Code ILJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1998
Date Received
May 1, 1997
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