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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 K070509
Device Name FISSO HOLDING SYSTEM
Applicant
BAITELLA AG
AMSTEL 320-I
AMSTERDAM,  NL 1017AP
Applicant Contact ANGELIKA SCHERP
Correspondent
BAITELLA AG
AMSTEL 320-I
AMSTERDAM,  NL 1017AP
Correspondent Contact ANGELIKA SCHERP
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/22/2007
Decision Date 03/22/2007
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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