MODIFICATION OF CUTINOVA HYDRO DRESSING (K984595) - FDA 510(k) Clearance

K984595 is an FDA 510(k) clearance for the MODIFICATION OF CUTINOVA HYDRO DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Beiersdorf-Jobt, Inc. (Charlotte, US). The FDA issued a Cleared decision on March 1, 1999 after a review of 63 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 Beiersdorf-Jobt, Inc. devices