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510(k) Premarket Notification

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Device Classification Name evacuator, gastro-urology
510(k) NumberK921451
Device NameEVACUATOR, GASTRO-UROLOGY
Applicant
NORTHGATE TECHNOLOGIES, INC.
3930 ventura dr.
arlington heights,  IL  60004
Contactdaniel kamm
Regulation Number876.4370
Classification Product Code
KQT  
Date Received03/26/1992
Decision Date 10/28/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Statement/Summary/Purged Status Statement only
Type Traditional
Reviewed by Third Party No
Expedited Review
 
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