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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 K973249
Device Name ENDOASSIST
Applicant
ARMSTRONG HEALTHCARE LTD.
RIVERLOCK HOUSE,
SPRING GARDENS ROAD
HIGH WYCOMBE,  GB HP13 7AG
Applicant Contact PATRICK A FINLAY
Correspondent
ARMSTRONG HEALTHCARE LTD.
RIVERLOCK HOUSE,
SPRING GARDENS ROAD
HIGH WYCOMBE,  GB HP13 7AG
Correspondent Contact PATRICK A FINLAY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/29/1997
Decision Date 11/26/1997
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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