Name: Predicase
Price: 199 USD

K-number	K901876
Device name	INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)
Applicant	Smith & Nephew United, Inc.
Product code	KOZ
Device class	Class I
Decision date	Jun 28, 1990
Decision	Substantially Equivalent for Some Indications
Regulation	878.4018

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 →

INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)

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