510(k) K012057

CASCADE BATH, MODEL 6900 by Penner Manufacturing, Inc. — Product Code ILJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2001
Date Received
July 2, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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