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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K091315
Device Name COVIDIEN EXTENDED TIP APPLICATOR
Applicant
Confluent Surgical,Inc
101a First Ave.
Waltham,  MA  02451
Applicant Contact SEAN REYNOLDS
Correspondent
Confluent Surgical,Inc
101a First Ave.
Waltham,  MA  02451
Correspondent Contact SEAN REYNOLDS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/04/2009
Decision Date 06/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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