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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K860758
Device Name VACO SUCTION ELECTRODE UNIT
Applicant
Zimmer Elektromedizin GmbH
Junkersstrabe 9
Postfach 22 80
7910 Neu-Ulm, Germany,  DE
Applicant Contact WOLFGANG KUNZE
Correspondent
Zimmer Elektromedizin GmbH
Junkersstrabe 9
Postfach 22 80
7910 Neu-Ulm, Germany,  DE
Correspondent Contact WOLFGANG KUNZE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received02/28/1986
Decision Date 05/02/1986
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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