Name: Predicase
Price: 199 USD

K-number	K232615
Device name	LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape))
Applicant	Devicor Medical Products, Inc.
Product code	NEU
Device class	Class II
Decision date	Jan 12, 2024
Decision	Substantially Equivalent
Regulation	878.4300

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Source

View the full FDA submission: accessdata.fda.gov

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LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape))

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

LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape))