K832699 - HYDRON WOUND DRESSING FAST SEAT KIT (FDA 510(k) Clearance)

K832699 is an FDA 510(k) clearance for the HYDRON WOUND DRESSING FAST SEAT KIT. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by National Patent Development Corp. (Mchenry, US). The FDA issued a Cleared decision on April 27, 1984 after a review of 261 days - an extended review cycle.

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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