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510(k) K914784

PAPILLION PROCTOSCOPE by Oldelft Corp. of America — Product Code KQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1992
Date Received
October 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Beam Limiting, X-Ray, Therapeutic
Device Class
Class II
Regulation Number
892.5900
Review Panel
RA
Submission Type

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  • K932848 — SIMULIX-MC CT EXTENSION (March 22, 1994)
  • K923584 — THERAPAX DXT 300 SERIES 3 (January 15, 1993)
  • K912466 — OLDELFT SIMULIX-MC (June 28, 1991)
  • K892659 — ELECTRODELCA (November 21, 1989)

Other clearances for product code KQA

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