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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, Ac-Powered
510(k) Number K921498
Device Name VER MED A10011 PNS DUAL ELEMENT ELECTRODE
Applicant
Vermont Medical, Inc.
Industrial Park
Bellows Falls,  VT  05101
Applicant Contact PAMELA SOPCZYK
Correspondent
Vermont Medical, Inc.
Industrial Park
Bellows Falls,  VT  05101
Correspondent Contact PAMELA SOPCZYK
Regulation Number868.2775
Classification Product Code
BXM  
Date Received03/31/1992
Decision Date 06/09/1993
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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