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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rotator, Prosthetic Heart Valve
510(k) Number K980016
Device Name MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
Applicant
Genzyme Surgical Product (Genzyme Biosurgery)
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
Genzyme Surgical Product (Genzyme Biosurgery)
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number870.3935
Classification Product Code
MOP  
Date Received01/02/1998
Decision Date 08/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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