Name: Predicase
Price: 199 USD

K-number	K043425
Device name	SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)
Applicant	Sheathing Technologies, Inc.
Product code	ITX
Device class	Class II
Decision date	Feb 28, 2005
Decision	Substantially Equivalent
Regulation	892.1570

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View the full FDA submission: accessdata.fda.gov

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SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)

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