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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 K933192
Device Name ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST.
Applicant
Access Surgical Intl., Inc.
Boat Yard Sq.
15 Caswell Ln.
Plymouth,  MA  02360
Applicant Contact PAMELA BELHUMER
Correspondent
Access Surgical Intl., Inc.
Boat Yard Sq.
15 Caswell Ln.
Plymouth,  MA  02360
Correspondent Contact PAMELA BELHUMER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/30/1993
Decision Date 11/18/1993
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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