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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K953417
Device Name MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
Applicant
Cook Pacemaker Corp.
P.O. Box 529
Rte. 66 River Rd.
Leechburg,  PA  15656
Applicant Contact RICHYARD E SHIREY
Correspondent
Cook Pacemaker Corp.
P.O. Box 529
Rte. 66 River Rd.
Leechburg,  PA  15656
Correspondent Contact RICHYARD E SHIREY
Regulation Number870.3610
Classification Product Code
DXY  
Date Received06/08/1995
Decision Date 09/29/1995
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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