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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 K040244
Device Name MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6
Applicant
The Microoptical Corporation
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact DANIEL J DILLON
Correspondent
The Microoptical Corporation
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact DANIEL J DILLON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/03/2004
Decision Date 03/24/2004
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
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