K133775 - EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING (FDA 510(k) Clearance)

K133775 is an FDA 510(k) clearance for the EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Exciton Technologies, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on March 26, 2014 after a review of 104 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.