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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K970864
FOIA Releasable 510(k) K970864
Device Name ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
Applicant
Arrow Intl., Inc.
3000 Bernville Rd.
Reading,  PA  19605
Applicant Contact THOMAS D NICKEL
Correspondent
Arrow Intl., Inc.
3000 Bernville Rd.
Reading,  PA  19605
Correspondent Contact THOMAS D NICKEL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/10/1997
Decision Date 10/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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