20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE (K972185) - FDA 510(k) Clearance

K972185 is an FDA 510(k) clearance for the 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Steripak, Ltd. (Runcorn, Cheshire, GB). The FDA issued a Cleared decision on March 5, 1998 after a review of 268 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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