Name: Predicase
Price: 199 USD

K-number	K782146
Device name	PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT
Applicant	Arco Medical Products Co.
Product code	DXY
Device class	Class III
Decision date	Dec 27, 1978
Decision	Substantially Equivalent — with Special Conditions
Regulation	870.3610

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Source

View the full FDA submission: accessdata.fda.gov

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PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT

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