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FDA 510(k) Applications for Medical Device Product Code "PBQ"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K220420
Coloplast A/S
Saffron Fixation System
06/10/2022
K230730
Escala Medical
Apyx
07/25/2023
K213783
Escala Medical
Apyx
04/05/2022
K042603
ETHICON, INC.
GYNECARE PROLENE FASTENER SYSTEM
12/22/2004
K130059
IBI ISRAEL BIOMEDICAL INNOVATIONS LTD.
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
07/29/2013
K120831
NEOMEDIC INTERNATIONAL S.L.
ANCHORSURE
10/12/2012
K160569
POP Medical Solutions
NeuGuide
07/06/2016
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