Name: Predicase
Price: 199 USD

K-number	K993781
Device name	SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED
Applicant	P.T. Vonix Latexindo Condom (Rubber) Mfg.
Product code	HIS
Device class	Class II
Decision date	Feb 2, 2000
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 →

SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED

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