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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K982518
Device Name AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
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 Number884.1720
Classification Product Code
HET  
Date Received07/20/1998
Decision Date 01/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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