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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Vascular
510(k) Number K961333
Device Name HEARTPORT MULTIFIRE CLIP APPLIER
Applicant
HEARTPORT, INC.
200 CHESAPEAKE DR.
REDWOOD CITY,  CA  94063
Applicant Contact ISABELLA R ABATI
Correspondent
HEARTPORT, INC.
200 CHESAPEAKE DR.
REDWOOD CITY,  CA  94063
Correspondent Contact ISABELLA R ABATI
Regulation Number870.3250
Classification Product Code
DSS  
Date Received04/08/1996
Decision Date 11/15/1996
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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