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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 K093194
Device Name MGB DISPOSABLE RETRIEVAL BAG LAPBAG
Applicant
MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)
SCHWARZSCHILDSTRASSE 6
BERLIN,  DE D-12489
Applicant Contact PATRICK GAENSICKE
Correspondent
MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)
SCHWARZSCHILDSTRASSE 6
BERLIN,  DE D-12489
Correspondent Contact PATRICK GAENSICKE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/09/2009
Decision Date 03/03/2010
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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