510(k) K001860

PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA by Homedics, Inc. — Product Code IMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2000
Date Received
June 19, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Paraffin
Device Class
Class II
Regulation Number
890.5110
Review Panel
PM
Submission Type