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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K852166
Device Name THERMO SHORTWAVE DIATHERMY
Applicant
Zimmer Elektromedizin GmbH
Junkersstrabe 9
Postfach 22 80
7910 Neu-Ulm, Germany,  DE
Applicant Contact DETLEF GANSERA
Correspondent
Zimmer Elektromedizin GmbH
Junkersstrabe 9
Postfach 22 80
7910 Neu-Ulm, Germany,  DE
Correspondent Contact DETLEF GANSERA
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received05/20/1985
Decision Date 09/30/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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