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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K052843
Device Name BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
Applicant
Busse Hospital Disposables, Inc.
75 Arkay Dr. P.O. Box 11067
Hauppauge,  NY  11788
Applicant Contact MUHAMAD ANSARI
Correspondent
Busse Hospital Disposables, Inc.
75 Arkay Dr. P.O. Box 11067
Hauppauge,  NY  11788
Correspondent Contact MUHAMAD ANSARI
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/07/2005
Decision Date 04/17/2006
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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