K934258 - SALINE WET DRESSING- STERILE (FDA 510(k) Clearance)

K934258 is an FDA 510(k) clearance for the SALINE WET DRESSING- STERILE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on November 24, 1993 after a review of 85 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 Trinity Laboratories, Inc. devices