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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 K990662
Device Name DISPOSABLE HEATING TUBING SET #7642HSES
Applicant
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
RUDOLF-DIESEL-RING 20
SAUERLACH,  DE D-82054
Applicant Contact S. GRUNWALD
Correspondent
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
RUDOLF-DIESEL-RING 20
SAUERLACH,  DE D-82054
Correspondent Contact S. GRUNWALD
Regulation Number884.1730
Classification Product Code
HIF  
Date Received03/01/1999
Decision Date 09/24/1999
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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