Name: Predicase
Price: 199 USD

K-number	K841383
Device name	CSPI ROTARY SURGICAL ASPIRATOR
Applicant	Custom Surgical Products, Inc.
Product code	—
Device class	Class unclassified
Decision date	Mar 26, 1984
Decision	Substantially Equivalent — with Special Conditions
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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CSPI ROTARY SURGICAL ASPIRATOR

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