K-number	K935783
Device name	MITRAFLEX CAVITY WOUND DRESSING
Applicant	Polymedica Industries, Inc.
Product code	KMF
Device class	Class I
Decision date	Feb 4, 1994
Decision	Substantially Equivalent for Some Indications
Regulation	880.5090

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

MITRAFLEX CAVITY WOUND DRESSING

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