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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
Predetermined Change
Control Plan Authorized		 No
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