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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, Battery-Powered
510(k) Number K011308
Device Name MULTISTIM
Applicant
PAJUNK GMBH
203 MAIN STREET, PMB 166
FLEMINGTON,,  NJ  08822
Applicant Contact LYNETTE HOWARD
Correspondent
PAJUNK GMBH
203 MAIN STREET, PMB 166
FLEMINGTON,,  NJ  08822
Correspondent Contact LYNETTE HOWARD
Regulation Number868.2775
Classification Product Code
BXN  
Date Received04/30/2001
Decision Date 11/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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