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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
510(k) Number K100992
Device Name NEURALMAS
Applicant
Innovative Surgical Solutions, LLC ("Iss")
55 Northern Blvd.
Suite 200
Great Neck,  NY  10021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Innovative Surgical Solutions, LLC ("Iss")
55 Northern Blvd.
Suite 200
Great Neck,  NY  10021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number874.1820
Classification Product Code
ETN  
Date Received04/09/2010
Decision Date 09/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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