Name: Predicase
Price: 199 USD

K-number	K161693
Device name	Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
Applicant	Stryker Sustainability Solutions
Product code	NLQ
Device class	Class U
Decision date	Feb 23, 2017
Decision	Substantially Equivalent
Regulation	—

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis

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