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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 K990732
Device Name LAP-WAVE 3000 (P07)
Applicant
W.O.M. WORLD OF MEDICINE, GMBH
194 BRANCH ST.
MANSFIELD,  MA  02048
Applicant Contact MICHAEL MCGRAIL
Correspondent
W.O.M. WORLD OF MEDICINE, GMBH
194 BRANCH ST.
MANSFIELD,  MA  02048
Correspondent Contact MICHAEL MCGRAIL
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/05/1999
Decision Date 07/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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