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510(k) K924741

OPTEC 3000 by Stereo Optical Co., Inc. — Product Code HKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1993
Date Received
September 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractometer, Ophthalmic
Device Class
Class I
Regulation Number
886.1760
Review Panel
OP
Submission Type

Other clearances by Stereo Optical Co., Inc.

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  • K863509 — OPTEC 1000 DMV (November 10, 1986)
  • K843042 — VISION TESTER (October 5, 1984)

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