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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 K030937
Device Name STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
Applicant
ARROW INTERNATIONAL, INC.
2400 BERNVILLE RD.
READING,  PA  19605 -9607
Applicant Contact BRANDON EPTING
Correspondent
ARROW INTERNATIONAL, INC.
2400 BERNVILLE RD.
READING,  PA  19605 -9607
Correspondent Contact BRANDON EPTING
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received03/25/2003
Decision Date 04/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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