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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Paraffin
510(k) Number K001860
Device Name PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
Applicant
Homedics, Inc.
3000 Pontiac Trl.
Commerce Township,  MI  48390
Applicant Contact MICHEAL NELSON
Correspondent
Homedics, Inc.
3000 Pontiac Trl.
Commerce Township,  MI  48390
Correspondent Contact MICHEAL NELSON
Regulation Number890.5110
Classification Product Code
IMC  
Date Received06/19/2000
Decision Date 08/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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