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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K935371
Device Name R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD
Applicant
R2 Medical Systems
5731 W. Howard St.
Niles,  IL  60714
Applicant Contact WILLIAM J SMIRLES
Correspondent
R2 Medical Systems
5731 W. Howard St.
Niles,  IL  60714
Correspondent Contact WILLIAM J SMIRLES
Regulation Number870.2360
Classification Product Code
DRX  
Subsequent Product Codes
DRO   LDD  
Date Received11/08/1993
Decision Date 12/02/1994
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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