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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K994340
Device Name CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
Applicant
HAI LABORATORIES, INC.
30 NORTHPOINT RD.
SOUND BEACH,  NY  11789 -1734
Applicant Contact RICHARD C LANZILLOTTO
Correspondent
HAI LABORATORIES, INC.
30 NORTHPOINT RD.
SOUND BEACH,  NY  11789 -1734
Correspondent Contact RICHARD C LANZILLOTTO
Regulation Number886.1570
Classification Product Code
HLI  
Date Received12/23/1999
Decision Date 09/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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