K973511 - KENDALL CURITY PETROLATUM GAUZE (FDA 510(k) Clearance)

K973511 is an FDA 510(k) clearance for the KENDALL CURITY PETROLATUM GAUZE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on December 16, 1997 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.

View all Kendall Healthcare Products Co. Div.Of Tyco Health devices