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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 K800178
Device Name EXTRACORP.'S INTERSEPT CUS. TUBING PK.
Applicant
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.4390
Classification Product Code
DWE  
Date Received01/28/1980
Decision Date 02/21/1980
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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