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510(k) K032400

LAFACI by Vision Pro, LLC — Product Code FYD

K032400 is an FDA 510(k) premarket notification submitted by Vision Pro, LLC for the device "LAFACI". The FDA issued a decision of Substantially Equivalent on May 7, 2004. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2004
Date Received
August 4, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

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FDA data resources