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510(k) K894839

OS-1 OCCLUSION SYSTEM - 1 by Medical, Inc. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
July 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type

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  • K823261 — INTERFACE TRANSFUSION BLOOD FILTER #30 (January 7, 1983)
  • K823259 — INTERFACE CARDIOTOMY BLOOD FILTER #50 (November 24, 1982)

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