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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 K011395
Device Name MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
Applicant
Medtronic Vascular
8299 Central Ave., NE
Mail Stop: P108
Minneapolis,  MN  55432
Applicant Contact CHARLES DOWD
Correspondent
Medtronic Vascular
8299 Central Ave., NE
Mail Stop: P108
Minneapolis,  MN  55432
Correspondent Contact CHARLES DOWD
Regulation Number870.3800
Classification Product Code
KRH  
Date Received05/07/2001
Decision Date 07/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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