K945675 - PREPPIES SKIN BARRIER WIPE (FDA 510(k) Clearance)

K945675 is an FDA 510(k) clearance for the PREPPIES SKIN BARRIER WIPE. 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 February 7, 1995 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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