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510(k) K881711

VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA. by Telectronics and Cordis Pacing Systems — Product Code DXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1988
Date Received
April 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implantable Pacemaker Pulse-Generator
Device Class
Class III
Regulation Number
870.3610
Review Panel
CV
Submission Type

Other clearances by Telectronics and Cordis Pacing Systems

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  • K881904 — CHANGE TO CATHODE POWDER SPECIFICATION (July 22, 1988)

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  • K952328 — NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (September 29, 1995)
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  • K940039 — PELLETHANE 75D (July 12, 1995)
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