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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K063018
Device Name GLASS LOSS OF RESISTANCE SYRINGE
Applicant
Busse Hospital Disposables, Inc.
75 Arkay Dr.
Hauppauge,  NY  11788
Applicant Contact MUHAMAD ANSARI
Correspondent
Busse Hospital Disposables, Inc.
75 Arkay Dr.
Hauppauge,  NY  11788
Correspondent Contact MUHAMAD ANSARI
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received10/02/2006
Decision Date 01/22/2007
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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