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510(k) K973642

ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 by Instrumentarium Imaging, Inc. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1997
Date Received
September 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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  • K924921 — INSTRUMENTARIUM MEGA4 HT (May 17, 1993)
  • K924472 — INSTRUMENTARIUM MEGA4 HT (May 3, 1993)
  • K923581 — INSTRUMENTARIUM MEGA4 HT (May 3, 1993)
  • K923352 — INSTRUMENTARIUM MEGA4 HT (October 6, 1992)

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