K-number	K020666
Device name	DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
Applicant	Baxter Healthcare Corp
Product code	FMF
Device class	Class II
Decision date	Jun 24, 2002
Decision	Substantially Equivalent
Regulation	880.5860

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 →

DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML

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