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FDA 510(k) Application Details - K231603
Device Classification Name
More FDA Info for this Device
510(K) Number
K231603
Device Name
Standard Staple-Line Reinforcement (SSLR23)
Applicant
Standard Bariatrics, Inc.
4300 Glendale Milford Road
Cincinnati, OH 45242 US
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Contact
Trevor Barton
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Regulation Number
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Classification Product Code
OXC
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More FDA Info for this Product Code
Date Received
06/01/2023
Decision Date
10/06/2023
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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