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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Urethral
510(k) Number K962611
Device Name BARD EAGLE INFLATION DEVICE
Applicant
Ryder Intl. Corp.
100 Curt Francis Rd.
Post Office Box 564
Arab,  AL  35016
Applicant Contact DAN CLARK
Correspondent
Ryder Intl. Corp.
100 Curt Francis Rd.
Post Office Box 564
Arab,  AL  35016
Correspondent Contact DAN CLARK
Regulation Number876.5520
Classification Product Code
KOE  
Date Received07/03/1996
Decision Date 10/21/1996
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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