Name: Predicase
Price: 199 USD

K-number	K862150
Device name	MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)
Applicant	Directed Energy, Inc.
Product code	EWG
Device class	Class II
Decision date	Sep 4, 1986
Decision	Substantially Equivalent for Some Indications
Regulation	874.4500

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Source

View the full FDA submission: accessdata.fda.gov

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MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)

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