K-number	K780485
Device name	PREBYPASS FILTER
Applicant	Delta Medical Industries
Product code	KRJ
Device class	Class II
Decision date	Apr 5, 1978
Decision	Substantially Equivalent
Regulation	870.4280

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Source

View the full FDA submission: accessdata.fda.gov

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PREBYPASS FILTER

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