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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 K822246
Device Name NONINVASIVE TEMPORARY PACEMAKER
Applicant
ROSS RESEARCH, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ROSS RESEARCH, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.5550
Classification Product Code
DRO  
Date Received07/29/1982
Decision Date 08/06/1982
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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