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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K895729
Device Name R2 PACE PAD, MODEL 480
Applicant
Darox Corp.
5731 W. Howard Ave.
Niles,  IL  60648
Applicant Contact WILLIAM J SMIRLES
Correspondent
Darox Corp.
5731 W. Howard Ave.
Niles,  IL  60648
Correspondent Contact WILLIAM J SMIRLES
Regulation Number870.5550
Classification Product Code
DRO  
Date Received09/25/1989
Decision Date 10/12/1989
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
Recalls CDRH Recalls
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