Name: Predicase
Price: 199 USD

K-number	K240978
Device name	SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
Applicant	MacroLux Medical Technology Co., Ltd.
Product code	HIH
Device class	Class II
Decision date	Aug 16, 2024
Decision	Substantially Equivalent
Regulation	884.1690

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Source

View the full FDA submission: accessdata.fda.gov

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SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)

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