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510(k) K900839

THE CAROLINA ROCKER by Artec Environmental Monitoring Division — Product Code KNN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1990
Date Received
February 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Components, Wheelchair
Device Class
Class I
Regulation Number
890.3920
Review Panel
PM
Submission Type

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  • K854573 — ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE (January 3, 1986)
  • K832512 — AIRWAY MASKS (January 17, 1984)
  • K830056 — ARTEC TWIST VALVE (March 9, 1983)

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