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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 K060182
Device Name TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE
Applicant
AUSTRALIAN SURGICAL DEVICES
2/11 PONDEROSA PARADE
WARRIEWOOD NSW,  AU 2102
Applicant Contact MARIO KUNA
Correspondent
AUSTRALIAN SURGICAL DEVICES
2/11 PONDEROSA PARADE
WARRIEWOOD NSW,  AU 2102
Correspondent Contact MARIO KUNA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/24/2006
Decision Date 09/07/2006
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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