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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esthesiometer
510(k) Number K143068
Device Name Medical Monofilament Sensory Screening Toool
Applicant
Medical Monofilament Manufacturing
121 Camelot Dr.
Plymouth,  MA  02360
Applicant Contact Michelle Hardiman
Correspondent
AlvaMed, Inc.
21 Phillip Ave.
Burlington,  MA  01803
Correspondent Contact Susan Hamann
Regulation Number882.1500
Classification Product Code
GXB  
Date Received10/24/2014
Decision Date 01/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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