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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K831769
Device Name VARIOUS CARDIOVASCULAR SURGICAL DEVICE
Applicant
RESEARCH INDUSTRIES CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
RESEARCH INDUSTRIES CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.4210
Classification Product Code
DWF  
Date Received06/01/1983
Decision Date 08/12/1983
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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