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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K974336
Device Name CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
Applicant
J-LLOYD MEDICAL, INC.
415 COMMERCE LN., SUITE 6
WEST BERLIN,  NJ  08091
Applicant Contact JAMES L SKAGGS
Correspondent
J-LLOYD MEDICAL, INC.
415 COMMERCE LN., SUITE 6
WEST BERLIN,  NJ  08091
Correspondent Contact JAMES L SKAGGS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/18/1997
Decision Date 02/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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