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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 K905164
Device Name TUBE DECLOGGER
Applicant
Nova Design Technologies, Ltd.
19 E. Central Ave.
Paoli,  PA  19301
Applicant Contact ANDREW J MILLIGAN
Correspondent
Nova Design Technologies, Ltd.
19 E. Central Ave.
Paoli,  PA  19301
Correspondent Contact ANDREW J MILLIGAN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/16/1990
Decision Date 02/13/1991
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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