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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 K823583
Device Name MYOTEST NERVE STIMULATOR
Applicant
Prothia USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Prothia USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.2775
Classification Product Code
BXN  
Date Received12/06/1982
Decision Date 12/30/1982
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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