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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K803277
Device Name TYGON TUBING
Applicant
ELECTROMEDICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ELECTROMEDICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.4390
Classification Product Code
DWE  
Date Received12/29/1980
Decision Date 01/13/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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