Name: Predicase
Price: 199 USD

K-number	K200053
Device name	DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
Applicant	Dannik
Product code	GCJ
Device class	Class II
Decision date	Apr 21, 2020
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)

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