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510(k) K000544

BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 by Labtician Ophthalmics, Inc. — Product Code HJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2000
Date Received
February 18, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reader, Prism, Ophthalmic
Device Class
Class I
Regulation Number
886.5810
Review Panel
OP
Submission Type

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