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510(k) K884650

RESUBMITTED SCANORA by Orion Corp. — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1989
Date Received
November 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

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  • K872301 — DENTOCULT-SM CULTURE-PADDLE (September 11, 1987)
  • K872058 — ORICULT-N CULTURE-PADDLE (June 10, 1987)

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