Name: Predicase
Price: 199 USD

K-number	K864011
Device name	EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES
Applicant	Fraass Survival Systems, Inc.
Product code	NAD
Device class	Class I
Decision date	Nov 22, 1986
Decision	Substantially Equivalent for Some Indications
Regulation	878.4020

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES

Everything you need for a 510(k) submission. Nothing you don't.