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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K912554
Device Name ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
Applicant
Baxter Healthcare Corp
P.O. Box 11150
Santa Ana,  CA  92711
Applicant Contact Roberta Hines
Correspondent
Baxter Healthcare Corp
P.O. Box 11150
Santa Ana,  CA  92711
Correspondent Contact Roberta Hines
Regulation Number870.3800
Classification Product Code
KRH  
Date Received06/11/1991
Decision Date 09/09/1991
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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