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510(k) K973064

KEELER TEARSCOPE-PLUS by Keeler Instruments, Inc. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1998
Date Received
August 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

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  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K990257 — KEELER PULSAIR 3000 NON CONTACT TONOMETER (March 25, 1999)
  • K970029 — KEELER SPECTRA INDIRECT OPHTHALMOSCOPE (April 2, 1997)

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