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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K061394
Device Name SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
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 Number868.5150
Classification Product Code
BSP  
Date Received05/19/2006
Decision Date 09/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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