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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Set, Administration, Intravascular
510(k) Number K952976
Device Name PLASTIC BLUNT CANNULA
Applicant
Marquette Medical, Inc.
1114 Benfield Blvd.,
Suite K
Millersville,  MD  21108
Applicant Contact EARL D MARQUETTE, JR.
Correspondent
Marquette Medical, Inc.
1114 Benfield Blvd.,
Suite K
Millersville,  MD  21108
Correspondent Contact EARL D MARQUETTE, JR.
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/27/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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