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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 K941438
Device Name OP-PNEU ELECTRONIC CO2
Applicant
Wisap/U.S.A.
W-8029 Sauerlach B.
Munchen,,  DE
Applicant Contact H. SEMM
Correspondent
Wisap/U.S.A.
W-8029 Sauerlach B.
Munchen,,  DE
Correspondent Contact H. SEMM
Regulation Number884.1730
Classification Product Code
HIF  
Date Received03/24/1994
Decision Date 05/11/1995
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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