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510(k) K252643

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled by Teleflex Medical Sdn. Bhd. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2026
Date Received
August 21, 2025
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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