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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 K090979
Device Name DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES
Applicant
ENCISION, INC.
6797 WINCHESTER CIR.
BOULDER,  CO  80301
Applicant Contact JUDITH V KING
Correspondent
ENCISION, INC.
6797 WINCHESTER CIR.
BOULDER,  CO  80301
Correspondent Contact JUDITH V KING
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HET  
Date Received04/07/2009
Decision Date 05/28/2009
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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