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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
Predetermined Change
Control Plan Authorized		 No
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