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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 K122565
Device Name ARC ENDOCUFF
Applicant
BODDINGTONS PLASTICS LTD
UNIT 6 WHEELBARROW PARK ESTATE
PATTENDEN LANE
TONBRIDGE, KENT,  GB TN12 9QL
Applicant Contact JOHN BOVIS
Correspondent
BSI HEALTHCARE
KITEMARK COURT, DAVY AVENUE
KNOWLHILL
MILTON KEYNES,  GB MK5 8PP
Regulation Number876.1500
Classification Product Code
FED  
Date Received08/22/2012
Decision Date 09/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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