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FDA 510(k) Application Details - K190331
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K190331
Device Name
Staple, Implantable
Applicant
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
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Contact
Aditi Iyengar
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
02/14/2019
Decision Date
11/22/2019
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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