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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 K082454
Device Name MICROMYST APPLICATOR, MODEL 20-5000
Applicant
Covidien
101a First Ave.
Waltham,  MA  02451
Applicant Contact VIRGINIA VETTER
Correspondent
Covidien
101a First Ave.
Waltham,  MA  02451
Correspondent Contact VIRGINIA VETTER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/26/2008
Decision Date 11/07/2008
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
Recalls CDRH Recalls
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