K-number	K182159
Device name	Strome-Blitzer Cytology Balloon
Applicant	Adn International, LLC
Product code	EOX
Device class	Class II
Decision date	Jun 13, 2019
Decision	Substantially Equivalent
Regulation	874.4710

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Source

View the full FDA submission: accessdata.fda.gov

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Strome-Blitzer Cytology Balloon

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