Class Class II

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (K240457)

K240457 2024-07-24 Traditional
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Description

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) by Pentax of America, Inc. — FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK240457
Clearance Date2024-07-24
Clearance TypeTraditional
Product CodeGEH
Regulation Number878.4350

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