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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 K072790
Device Name CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
Applicant
Confluent Surgical,Inc
101a First Ave.
Waltham,  MA  02451
Applicant Contact VIRGINIA VETTER
Correspondent
Confluent Surgical,Inc
101a First Ave.
Waltham,  MA  02451
Correspondent Contact VIRGINIA VETTER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/01/2007
Decision Date 01/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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