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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 K001533
Device Name SURGIFLATOR-40
Applicant
W.O.M. GMHB
194 BRANCH ST.
MANSFIELD,  MA  02048
Applicant Contact MICHAEL MCGRAIL
Correspondent
W.O.M. GMHB
194 BRANCH ST.
MANSFIELD,  MA  02048
Correspondent Contact MICHAEL MCGRAIL
Regulation Number884.1730
Classification Product Code
HIF  
Date Received05/17/2000
Decision Date 07/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
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