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510(k) K854941

PMS PERCUTANEOUS PUNCTURE NEEDLE by Professional Medical Services — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1986
Date Received
December 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K884577 — PROCEDURE READY TRAYS (August 1, 1989)
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  • K884497 — CONTROL SYRINGE (December 12, 1988)
  • K872448 — BLOOD CONTAINMENT PACK (November 17, 1987)
  • K864555 — 3 RING ATTACHMENT (December 1, 1986)

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