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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 K033589
Device Name BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR
Applicant
Micromedics, Inc.
1285 Corporate Center Dr.,
#150
Eagan,  MN  55121
Applicant Contact CHARLES K GROTE
Correspondent
Micromedics, Inc.
1285 Corporate Center Dr.,
#150
Eagan,  MN  55121
Correspondent Contact CHARLES K GROTE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/13/2003
Decision Date 10/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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