Name: Predicase
Price: 199 USD

K-number	K080174
Device name	PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C
Applicant	Cardio Med Supplies, Inc.
Product code	LHI
Device class	Class II
Decision date	Apr 23, 2008
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C

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