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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 K121403
Device Name CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
Applicant
Teleflex, Inc.
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact PAUL AMUDALA
Correspondent
Teleflex, Inc.
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact PAUL AMUDALA
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received05/10/2012
Decision Date 06/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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