Name: Predicase
Price: 199 USD

K-number	K031014
Device name	HI-FLO THERME PNEU 45, WISAP #7083, 7083V
Applicant	Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Product code	HIF
Device class	Class II
Decision date	Jun 27, 2003
Decision	Substantially Equivalent
Regulation	884.1730

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Source

View the full FDA submission: accessdata.fda.gov

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HI-FLO THERME PNEU 45, WISAP #7083, 7083V

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