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510(k) K001439

ORTHOCEPH OC100 D by Instrumentarium Corp. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2000
Date Received
May 8, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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  • K934478 — ALPHA STEREO (January 31, 1995)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (July 22, 1993)
  • K930338 — ORTHOCEPH OC100 (April 27, 1993)

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