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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 K051073
Device Name MIDIVIEW SERIES OF MICROENDOSCOPES
Applicant
MILLENNIUM DEVICES, INC.
250 GIBBS RD.
ISLANDIA,  NY  11749 -2697
Applicant Contact JOSEPH LIBRIZZI
Correspondent
MILLENNIUM DEVICES, INC.
250 GIBBS RD.
ISLANDIA,  NY  11749 -2697
Correspondent Contact JOSEPH LIBRIZZI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/26/2005
Decision Date 05/17/2006
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
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