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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K960969
Device Name GALVA 5-T
Applicant
Zimmer Elektromedizin GmbH
9 Junkersstrabe
D7910 Neu-Ulm,  DE
Applicant Contact DUCHESS GRANGER
Correspondent
Zimmer Elektromedizin GmbH
9 Junkersstrabe
D7910 Neu-Ulm,  DE
Correspondent Contact DUCHESS GRANGER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/11/1996
Decision Date 05/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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