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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Marker, Ostia, Aorto-Saphenous Vein
510(k) Number K895369
Device Name VOSS GRAFT MARKER
Applicant
Voss Medical Products
4227 Centergate
San Antonio,  TX  78217
Applicant Contact STEVE HOLLOWAY
Correspondent
Voss Medical Products
4227 Centergate
San Antonio,  TX  78217
Correspondent Contact STEVE HOLLOWAY
Classification Product Code
KPK  
Date Received08/29/1989
Decision Date 09/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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