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510(k) Premarket Notification Database
Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K072756
Device Name NON-IV ADAPTER FOR INFANT NG TUBE
PROMEDIC, INC.
Applicant 3460 pointe creek ct., #102
bonita springs, FL 34134 201
Contact paul dryden
Regulation Number 876.5980
Classification Product Code KNT
Date Received 09/27/2007
Decision Date 12/19/2007
Decision substantially equivalent - kit (SK)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Statement/Summary/Purged Status Summary only
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Database Updated 03/06/2009
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=26002 (1 of 2)3/12/2009 3:02:56 PM
FDA > CDRH > 510(k) Premarket Notification Database Search
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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=26002 (2 of 2)3/12/2009 3:02:56 PM