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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 K770356
Device Name ANESTHESIA KIT, EPIDURAL, SINGLE SHOT
Applicant
ARROW INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ARROW INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received02/22/1977
Decision Date 03/01/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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