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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 K883905
Device Name ARROW PNEUMOTHORAX KIT, AK-01500
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 Received09/15/1988
Decision Date 01/19/1989
Decision Substantially Equivalent - With Drug (SESD)
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
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