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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 K061172
Device Name PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
Applicant
PAJUNK GMBH MEDIZINTECHNOLOGIE
106 EAST 5TH AVENUE
MOUNT DORA,  FL  32757
Applicant Contact LYNETTE L HOWARD
Correspondent
PAJUNK GMBH MEDIZINTECHNOLOGIE
106 EAST 5TH AVENUE
MOUNT DORA,  FL  32757
Correspondent Contact LYNETTE L HOWARD
Regulation Number868.2775
Classification Product Code
BXN  
Date Received04/27/2006
Decision Date 10/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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