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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K942044
FOIA Releasable 510(k) K942044
Device Name BARD ENDOSCOPIC OVERTUBE
Applicant
C.R. Bard, Inc.
200 Ames Pond Dr.
Tewksbury,  MA  01876
Applicant Contact JOHN A DELUCIA
Correspondent
C.R. Bard, Inc.
200 Ames Pond Dr.
Tewksbury,  MA  01876
Correspondent Contact JOHN A DELUCIA
Regulation Number876.1500
Classification Product Code
FED  
Date Received04/28/1994
Decision Date 06/10/1994
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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