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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 K141285
Device Name BUSSE EXTENSION SET
Applicant
Busse Hospital Disposables
75 Arkay Dr.
Hauppauge,  NY  11788 -3707
Applicant Contact MUHAMAD ANSARI
Correspondent
Busse Hospital Disposables
75 Arkay Dr.
Hauppauge,  NY  11788 -3707
Correspondent Contact MUHAMAD ANSARI
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPK  
Date Received05/16/2014
Decision Date 02/19/2015
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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