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510(k) K243371

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 by Byonyks Pvt, Ltd. — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2025
Date Received
October 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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