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FDA 510(k) Application Details - K130324
Device Classification Name
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510(K) Number
K130324
Device Name
STATSEAL DISC
Applicant
BIOLIFE, LLC
9163 25TH COURT EAST
SARASOTA, FL 34243 US
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Contact
CLAUDIA MASSELINK
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Regulation Number
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Classification Product Code
QSY
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Date Received
02/08/2013
Decision Date
07/09/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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