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FDA 510(k) Applications Submitted by Gayatri Ghadge
FDA 510(k) Number
Submission Date
Device Name
Applicant
K220420
02/14/2022
Saffron Fixation System
Coloplast A/S
K170583
02/28/2017
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
Medtronic, Inc.
K221874
06/28/2022
Altis Single Incision Sling System
Coloplast A/S
K213185
09/29/2021
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
Coloplast Corp
K213186
09/29/2021
NovoFlow Reinforced Ureteral Stent
Coloplast Corp
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