K952948 - SALINE DRESSING (FDA 510(k) Clearance)

K952948 is an FDA 510(k) clearance for the SALINE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on August 16, 1995 after a review of 51 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 Busse Hospital Disposables, Inc. devices