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510(k) K962638

TONOCAP, TC-200 AND ACCESSORY CATHETERS by Instrumentarium Corp. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1997
Date Received
July 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

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  • K930338 — ORTHOCEPH OC100 (April 27, 1993)

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