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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, rigid
510(k) Number K083840
Device Name MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
Applicant
MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH
ESCAD-STR 3
PFULLENDORF,  DE D-88630
Applicant Contact CHRISTINE STROBEL
Correspondent
MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH
ESCAD-STR 3
PFULLENDORF,  DE D-88630
Correspondent Contact CHRISTINE STROBEL
Regulation Number876.1500
Classification Product Code
GCM  
Date Received12/24/2008
Decision Date 09/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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