Name: Predicase
Price: 199 USD

K-number	K023066
Device name	DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
Applicant	Sodemsystems
Product code	HBB
Device class	Class II
Decision date	Nov 25, 2002
Decision	Substantially Equivalent
Regulation	882.4370

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Source

View the full FDA submission: accessdata.fda.gov

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DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)

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