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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K023209
Device Name INSIGHT MILLENNIUM III
Applicant
Fasstech
76 Treble Cove Rd.
Bldg. #2
North Billerica,  MA  01862
Applicant Contact LEE BRODY
Correspondent
Fasstech
76 Treble Cove Rd.
Bldg. #2
North Billerica,  MA  01862
Correspondent Contact LEE BRODY
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Code
HCC  
Date Received09/26/2002
Decision Date 10/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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