Name: Predicase
Price: 199 USD

K-number	K946188
Device name	CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
Applicant	Cardiac Control Systems, Inc.
Product code	DXY
Device class	Class III
Decision date	May 15, 1995
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	870.3610

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Source

View the full FDA submission: accessdata.fda.gov

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CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER

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