Name: Predicase
Price: 199 USD

K-number	K974323
Device name	LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT
Applicant	Reddy Medtech Health Products , Ltd.
Product code	HIS
Device class	Class II
Decision date	Feb 10, 1998
Decision	Substantially Equivalent
Regulation	884.5300

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 →

LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT

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