Name: Predicase
Price: 199 USD

K-number	K971547
Device name	PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS
Applicant	Playtex Products, Inc.
Product code	HIL
Device class	Class II
Decision date	Jun 19, 1997
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 →

PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS

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