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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 K121525
Device Name PERIFUSE CATHETER
Applicant
Smiths Medical Asd, Inc.
10 Bowman Dr.
Keene,  NH  03431
Applicant Contact CHRISTINE LLOYD
Correspondent
Smiths Medical Asd, Inc.
10 Bowman Dr.
Keene,  NH  03431
Correspondent Contact CHRISTINE LLOYD
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received05/23/2012
Decision Date 08/02/2012
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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