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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 K861935
Device Name MODEL 100 NERVE STIMULATOR
Applicant
National Medical Sales, Inc.
23881 Via Fabricante
Unit 512
Mission Viejo,  CA  92691
Applicant Contact WILLIAM D BURCH
Correspondent
National Medical Sales, Inc.
23881 Via Fabricante
Unit 512
Mission Viejo,  CA  92691
Correspondent Contact WILLIAM D BURCH
Regulation Number868.2775
Classification Product Code
BXN  
Date Received05/20/1986
Decision Date 06/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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