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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 K891281
Device Name INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH.
Applicant
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.s
Reading,  PA  19610
Applicant Contact THOMAS D NICKEL
Correspondent
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.s
Reading,  PA  19610
Correspondent Contact THOMAS D NICKEL
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received03/09/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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