BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080

Reader, Prism, Ophthalmic

LABTICIAN OPHTHALMICS, INC.

The following data is part of a premarket notification filed by Labtician Ophthalmics, Inc. with the FDA for Boucher Degroot Head Positioning Glasses, Model 8080.

Pre-market Notification Details

Device IDK000544
510k NumberK000544
Device Name:BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
ClassificationReader, Prism, Ophthalmic
Applicant LABTICIAN OPHTHALMICS, INC. 2140 WINSTON PARK DR., UNIT 6 Oakville, Ontario,  CA L6h 5v5
ContactR. David Sculati
CorrespondentR. David Sculati
LABTICIAN OPHTHALMICS, INC. 2140 WINSTON PARK DR., UNIT 6 Oakville, Ontario,  CA L6h 5v5
Product CodeHJX  
CFR Regulation Number886.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-18
Decision Date2000-03-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00871321002949 K000544 000

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