Name: Predicase
Price: 199 USD

K-number	K012088
Device name	NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
Applicant	Nastech Pharmaceutical Company, Inc.
Product code	KNW
Device class	Class II
Decision date	Dec 18, 2001
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT

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