Name: Predicase
Price: 199 USD

K-number	K974758
Device name	HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
Applicant	Hydrox Laboratories
Product code	JOL
Device class	Class II
Decision date	Mar 9, 1998
Decision	Substantially Equivalent
Regulation	880.6740

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 →

HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE

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