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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 K001587
Device Name 19 GA PLASTIC REINFORCED EPIDURAL CATHETER
Applicant
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Applicant Contact THOMAS D NICKEL
Correspondent
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Correspondent Contact THOMAS D NICKEL
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received05/23/2000
Decision Date 07/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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