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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name patch, pledget and intracardiac, petp, ptfe, polypropylene
510(k) Number K921895
Device Name TISSUE PATCH, TISSUE GRAFT
Applicant
BIO-VASCULAR, INC.
2670 PATTON RD.
SAINT PAUL,  MN  55113
Applicant Contact BRUCE MACFARLANE
Correspondent
BIO-VASCULAR, INC.
2670 PATTON RD.
SAINT PAUL,  MN  55113
Correspondent Contact BRUCE MACFARLANE
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received04/22/1992
Decision Date 11/04/1992
Decision SE - Postmarket Surveillance Required (SESP)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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