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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 K122027
Device Name ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
Applicant
Arrow International, Inc.
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact PAUL AMUDALA
Correspondent
Arrow International, Inc.
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact PAUL AMUDALA
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received07/11/2012
Decision Date 08/28/2012
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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