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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K953651
Device Name DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM
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 Number870.1220
Classification Product Code
DRF  
Date Received08/04/1995
Decision Date 11/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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