Name: Predicase
Price: 199 USD

K-number	K151405
Device name	Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
Applicant	Surgical Instrument Services and Savings(Dba Medline Renewal
Product code	NLQ
Device class	Class U
Decision date	Jan 26, 2016
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology

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