Name: Predicase
Price: 199 USD

K-number	K034025
Device name	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
Applicant	Nmt Medical, Inc.
Product code	DYB
Device class	Class II
Decision date	Mar 26, 2004
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC

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