Name: Predicase
Price: 199 USD

K-number	K070360
Device name	KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
Applicant	Kirwan Surgical Products, Inc.
Product code	LFL
Device class	Class U
Decision date	Aug 7, 2007
Decision	Substantially Equivalent
Regulation	—

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 →

KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601

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