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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 K021567
Device Name STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
Applicant
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Applicant Contact WILLIAM G MCLAIN
Correspondent
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Correspondent Contact WILLIAM G MCLAIN
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received05/13/2002
Decision Date 06/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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