Name: Predicase
Price: 199 USD

K-number	K032667
Device name	FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)
Applicant	Focus Medical, LLC
Product code	GEX
Device class	Class II
Decision date	Jan 23, 2004
Decision	Substantially Equivalent
Regulation	878.4810

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 →

FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)

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