Name: Predicase
Price: 199 USD

K-number	K915188
Device name	MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD
Applicant	Cook Pacemaker Corp.
Product code	DTB
Device class	Class III
Decision date	Sep 11, 1992
Decision	Substantially Equivalent — with Special Conditions
Regulation	870.3680

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Source

View the full FDA submission: accessdata.fda.gov

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MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD

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