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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K011510
Device Name MULTI HI-FLO PNEU, WISAP #7080
Applicant
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Rudolf-Diesel-Ring 20
Sauerlach,  DE D-82054
Applicant Contact HORST SEMM
Correspondent
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Rudolf-Diesel-Ring 20
Sauerlach,  DE D-82054
Correspondent Contact HORST SEMM
Regulation Number884.1730
Classification Product Code
HIF  
Date Received05/16/2001
Decision Date 04/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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