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510(k) K890471

PMS ANGIO DRAPE by Professional Medical Services — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1989
Date Received
January 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

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  • K884577 — PROCEDURE READY TRAYS (August 1, 1989)
  • K884497 — CONTROL SYRINGE (December 12, 1988)
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  • K864555 — 3 RING ATTACHMENT (December 1, 1986)
  • K854941 — PMS PERCUTANEOUS PUNCTURE NEEDLE (April 16, 1986)

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