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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name reader, prism, ophthalmic
510(k) Number K000544
Device Name BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
Applicant
LABTICIAN OPHTHALMICS, INC.
2140 WINSTON PARK DR., UNIT 6
OAKVILLE, ONTARIO,  CA L6H 5V5
Applicant Contact R. DAVID SCULATI
Correspondent
LABTICIAN OPHTHALMICS, INC.
2140 WINSTON PARK DR., UNIT 6
OAKVILLE, ONTARIO,  CA L6H 5V5
Correspondent Contact R. DAVID SCULATI
Regulation Number886.5810
Classification Product Code
HJX  
Date Received02/18/2000
Decision Date 03/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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