Name: Predicase
Price: 199 USD

K-number	K090156
Device name	ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000
Applicant	Wcm Waste & Compliance Management, Inc.
Product code	FMI
Device class	Class II
Decision date	Sep 1, 2009
Decision	Substantially Equivalent
Regulation	880.5570

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 →

ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000

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