Name: Predicase
Price: 199 USD

K-number	K221033
Device name	UniPrime A, UniPrime E, UniPrime E/C
Applicant	S&C Polymer Silicon- Und Composite Spezialitäten GmbH
Product code	KLE
Device class	Class II
Decision date	Jul 6, 2022
Decision	Substantially Equivalent
Regulation	872.3200

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Source

View the full FDA submission: accessdata.fda.gov

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UniPrime A, UniPrime E, UniPrime E/C

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