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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K924385
Device Name NEW HYDROPHILIC COATING FOR WIRE GUIDES
Applicant
ARROW INTL., INC.
P.O. BOX 12888
3000 BERNVILLE RD
READING,  PA  19612
Applicant Contact THOMAS D NICKEL
Correspondent
ARROW INTL., INC.
P.O. BOX 12888
3000 BERNVILLE RD
READING,  PA  19612
Correspondent Contact THOMAS D NICKEL
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/24/1992
Decision Date 08/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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