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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K071579
Device Name PEF TUBE
Applicant
N.M. Beale Co., Inc.
5 Whitcomb Aveneue
Ayer,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
N.M. Beale Co., Inc.
5 Whitcomb Aveneue
Ayer,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/08/2007
Decision Date 11/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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