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FDA 510(k) Application Details - K021051
Device Classification Name
Ring, Annuloplasty
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510(K) Number
K021051
Device Name
Ring, Annuloplasty
Applicant
SULZER CARBOMEDICS, INC.
1300 EAST ANDERSON LN.
AUSTIN, TX 78752 US
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Contact
TEFFANY HANKINSON
Other 510(k) Applications for this Contact
Regulation Number
870.3800
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Classification Product Code
KRH
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More FDA Info for this Product Code
Date Received
04/01/2002
Decision Date
04/23/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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