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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 K051585
Device Name F-400 SYSTEM
Applicant
MAUNA KEA TECHNOLOGIES
9, RUE D'ENGHIEN
PARIS,  FR 75010
Applicant Contact ALEXANDRE LOISEAU
Correspondent
MAUNA KEA TECHNOLOGIES
9, RUE D'ENGHIEN
PARIS,  FR 75010
Correspondent Contact ALEXANDRE LOISEAU
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/15/2005
Decision Date 09/06/2005
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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