Name: Predicase
Price: 199 USD

K-number	K201313
Device name	CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
Applicant	Aziyo Biologics, Inc.
Product code	FTM
Device class	Class II
Decision date	Jun 15, 2020
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)

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