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510(k) K925755

DE LUXE by Rudolf Riester GmbH & Co. KG — Product Code HLJ

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 3, 1993
Date Received
November 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

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  • K950913 — PERFECT, ENT SET, PRAKTIKANT, DE LUXE (May 12, 1995)
  • K945541 — SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE (May 8, 1995)

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