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FDA 510(k) Application Details - K051621
Device Classification Name
Prosthesis, Esophageal
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510(K) Number
K051621
Device Name
Prosthesis, Esophageal
Applicant
ALVEOLUS, INC.
9013 PERIMETER WOODS SUITE A
CHARLOTTE, NC 28216 US
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Contact
DONALD V CANAL
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Regulation Number
878.3610
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Classification Product Code
ESW
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More FDA Info for this Product Code
Date Received
06/20/2005
Decision Date
07/11/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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