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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 K953232
Device Name HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE
Applicant
Hollister, Inc.
2000 Hollister Dr.
Libertyville,  IL  60048
Applicant Contact JOSEPH S TOKARZ
Correspondent
Hollister, Inc.
2000 Hollister Dr.
Libertyville,  IL  60048
Correspondent Contact JOSEPH S TOKARZ
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/10/1995
Decision Date 08/18/1995
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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