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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 K944974
Device Name ACCESS POINT
Applicant
Access Surgical Intl., Inc.
Boat Yard Sq.
15 Caswell Ln.
Plymouth,  MA  02360
Applicant Contact PAMELA MYETTE
Correspondent
Access Surgical Intl., Inc.
Boat Yard Sq.
15 Caswell Ln.
Plymouth,  MA  02360
Correspondent Contact PAMELA MYETTE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/11/1994
Decision Date 11/08/1994
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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