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FDA 510(k) Application Details - K982753
Device Classification Name
Prosthesis, Nose, Internal
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510(K) Number
K982753
Device Name
Prosthesis, Nose, Internal
Applicant
SEARE BIOMEDICAL CORP.
3190 CHULA VISTA CIRCLE
SALT LAKE CITY, UT 84121 US
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Contact
WILLIAM JOHN SEARE JR
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Regulation Number
878.3680
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Classification Product Code
FZE
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More FDA Info for this Product Code
Date Received
08/06/1998
Decision Date
09/30/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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