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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 K833631
Device Name THERMAMED BATH
Applicant
Bernlit Enterprises, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bernlit Enterprises, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5110
Classification Product Code
IMC  
Date Received10/17/1983
Decision Date 11/28/1983
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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