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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 K061737
Device Name LOSS OF RESISTANCE SYRINGE
Applicant
ROBERT BUSSE & CO., INC.
P.O. BOX 11067
HAUPPAUGE,  NY  11788
Applicant Contact MUHAMAD ANSARI
Correspondent
ROBERT BUSSE & CO., INC.
P.O. BOX 11067
HAUPPAUGE,  NY  11788
Correspondent Contact MUHAMAD ANSARI
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received06/20/2006
Decision Date 12/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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