510(k) K052479

MBATH 1000 (60) by Enneking Medical, Inc. — Product Code ILJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2006
Date Received
September 9, 2005
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