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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K093920
Device Name BUSSE EPIDURAL CATHETER KIT
Applicant
Busse Hospital Disposables
75 Arkay Dr.
Hauppauge,  NY  11788
Applicant Contact MUHAMAD ANSARI
Correspondent
Busse Hospital Disposables
75 Arkay Dr.
Hauppauge,  NY  11788
Correspondent Contact MUHAMAD ANSARI
Regulation Number868.5120
Classification Product Code
BSO  
Date Received12/22/2009
Decision Date 08/06/2010
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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