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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 K992513
Device Name THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
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 Received07/26/1999
Decision Date 03/17/2000
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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