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FDA 510(k) Application Details - K210278
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K210278
Device Name
Staple, Implantable
Applicant
Standard Bariatrics
4362 Glendale Milford Rd.
Cincinnati, OH 45242 US
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Contact
Alison Sathe
Other 510(k) Applications for this Contact
Regulation Number
878.4750
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Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
02/01/2021
Decision Date
04/28/2021
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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