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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, muscle monitoring
510(k) Number K043373
Device Name DOLOTENS DENTAL TM 1
Applicant
NEUROMUSCULAR TECHNOLOGIES, INC.
17720 JEAN WAY
#200
LAKE OSWEGO,  OR  97035
Applicant Contact MARIE JENSEN
Correspondent
NEUROMUSCULAR TECHNOLOGIES, INC.
17720 JEAN WAY
#200
LAKE OSWEGO,  OR  97035
Correspondent Contact MARIE JENSEN
Regulation Number890.1375
Classification Product Code
KZM  
Date Received12/08/2004
Decision Date 09/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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