Name: Predicase
Price: 199 USD

K-number	K083780
Device name	SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
Applicant	Audio Technologies S.R.L.
Product code	ETA
Device class	Class II
Decision date	Mar 23, 2009
Decision	Substantially Equivalent
Regulation	874.3495

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Source

View the full FDA submission: accessdata.fda.gov

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SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2

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