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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 K940587
Device Name FLEX-I-PORT
Applicant
Access Surgical Intl., Inc.
15 Caswell Ln., Boatyard Sq.
Plymouth,  MA  02360
Applicant Contact LYNETTE LYLE HOWARD
Correspondent
Access Surgical Intl., Inc.
15 Caswell Ln., Boatyard Sq.
Plymouth,  MA  02360
Correspondent Contact LYNETTE LYLE HOWARD
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/08/1994
Decision Date 03/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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