Name: Predicase
Price: 199 USD

K-number	K160337
Device name	Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
Applicant	Bam Corporation Limited
Product code	QPC
Device class	Class II
Decision date	Jul 7, 2017
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns

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