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510(k) K861436

SOF SET, MODELS 111 AND 112 by Pacesetter Systems — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1986
Date Received
April 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K895447 — ENDOCARDIAL SCREW-IN LEAD MODEL 1020T (December 20, 1989)
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  • K885267 — VS-1 MODEL NUMBER 251K PULSE GENERATOR (March 28, 1989)
  • K890547 — SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS (March 22, 1989)
  • K884733 — AFP MODEL 262T PULSE GENERATOR (February 10, 1989)
  • K883087 — PROLOG MP 658M PULSE GENERATOR (September 14, 1988)

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