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FDA 510(k), K231849, MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
FDA 510(k), K231849, MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
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$49.00 USD
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Sale price
$49.00 USD
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510(K) Number: K231849
Device Name: MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
Manufacturer: Brad Roynon
Device Classification Name: Set, Administration, For Peritoneal Dialysis, Disposable
Regulation Number: KDJ
Classification Product Code: KXA
Date Received: 06/23/2023
Decision Date: 03/12/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
Manufacturer: Brad Roynon
Device Classification Name: Set, Administration, For Peritoneal Dialysis, Disposable
Regulation Number: KDJ
Classification Product Code: KXA
Date Received: 06/23/2023
Decision Date: 03/12/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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