Medical Device Manufacturer · US , Rochester, , NY

Paneffort, LLC

2 submissions · 2 cleared · Since 2022

Total

Cleared

Denied

Paneffort, LLC — FDA 510(k) Submissions

Paneffort, LLC has submitted 2 FDA 510(k) premarket notifications since 2022, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Gown, Isolation, Surgical, Mask, Surgical . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

Paneffort AAMI Level 3 Isolation Gown

K212717 · FYC Gown, Isolation, Surgical · General Hospital

Nov 2022 460d

Paneffort 3-ply Surgical and Procedural Masks

K221409 · FXX Mask, Surgical · General Hospital

Jul 2022 70d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Paneffort, LLC

Paneffort, LLC — FDA 510(k) Submissions

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