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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K870572
Device Name ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT
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 Number880.6740
Classification Product Code
JOL  
Date Received02/10/1987
Decision Date 05/26/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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