Name: Predicase
Price: 199 USD

K-number	K111458
Device name	GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
Applicant	Gri Medical & Electronic Technology Co., Ltd.
Product code	KKX
Device class	Class II
Decision date	Dec 1, 2011
Decision	Substantially Equivalent
Regulation	878.4370

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 →

GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS

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