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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 K920262
Device Name ONAT BALLOONED NASOGASTRIC TUBE
Applicant
Macdonald Medical Devices, Inc.
611 W. Johnson Ave.
Cheshire,  CT  06410
Applicant Contact ERIC N RANDALL
Correspondent
Macdonald Medical Devices, Inc.
611 W. Johnson Ave.
Cheshire,  CT  06410
Correspondent Contact ERIC N RANDALL
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/21/1992
Decision Date 04/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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