Name: Predicase
Price: 199 USD

K-number	K101417
Device name	BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200
Applicant	Medipurpose Pte. , Ltd.
Product code	FMK
Device class	Class II
Decision date	Oct 19, 2010
Decision	Substantially Equivalent
Regulation	878.4850

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 →

BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200

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