Name: Predicase
Price: 199 USD

K-number	K160752
Device name	HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length
Applicant	Ethicon Endo-Suregery, LLC
Product code	LFL
Device class	Class U
Decision date	Jun 29, 2016
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length

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