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510(k) K041574

CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 by Guidant Corporation — Product Code DTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2004
Date Received
June 14, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker Lead Adaptor
Device Class
Class II
Regulation Number
870.3620
Review Panel
CV
Submission Type

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  • K041762 — FINISHING WIRE SUPPORTRAK (August 6, 2004)

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