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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 K011189
Device Name VIADUCT MICROENDOSCOPE AND ACCESSORIES
Applicant
ACUEITY, INC.
15 INDUSTRIAL PARK EAST
OXFORD,  MA  01540
Applicant Contact MARYBETH FECTEAU
Correspondent
ACUEITY, INC.
15 INDUSTRIAL PARK EAST
OXFORD,  MA  01540
Correspondent Contact MARYBETH FECTEAU
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/18/2001
Decision Date 07/16/2001
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
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