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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 K842423
Device Name PARA THERM BATH
Applicant
Grimm Scientific Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Grimm Scientific Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5110
Classification Product Code
IMC  
Date Received06/20/1984
Decision Date 06/28/1984
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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