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510(k) K210352

GGM Breathing Circuit Bacterial Filter by Great Group Medical Co, Ltd. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2022
Date Received
February 8, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

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