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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 K133375
Device Name BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR
Applicant
Banyan Medical, LLC
89 Bellows St.
Warwick,  RI  02888
Applicant Contact TAMMY HEALEY
Correspondent
Banyan Medical, LLC
89 Bellows St.
Warwick,  RI  02888
Correspondent Contact TAMMY HEALEY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/04/2013
Decision Date 01/17/2014
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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