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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, peripheral, electric
510(k) Number K002889
Device Name PNS MAGNETIC STIMULATOR SYSTEM
Applicant
NEOTONUS, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
NEOTONUS, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number868.2775
Classification Product Code
KOI  
Subsequent Product Code
GWF  
Date Received09/15/2000
Decision Date 04/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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