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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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