K994339 - HYCURE ORAL / HYCURE ORAL SMART GEL (FDA 510(k) Clearance)

K994339 is an FDA 510(k) clearance for the HYCURE ORAL / HYCURE ORAL SMART GEL. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by The Hymed Group Corp. (Bethlehem, US). The FDA issued a Cleared decision on March 22, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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