K-number	K862353
Device name	TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION)
Applicant	Tambrands, Inc.
Product code	HIL
Device class	Class II
Decision date	Jul 9, 1986
Decision	Substantially Equivalent
Regulation	884.5460

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION)

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