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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K850006
Device Name TENS
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
Date Received01/02/1985
Decision Date 12/20/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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