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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K844321
Device Name CUSTOM LITE
Applicant
Buchmann Optical Industries
216 Midland Ave.
Saddle Brook,  NY  07662
Applicant Contact CEURREMANS
Correspondent
Buchmann Optical Industries
216 Midland Ave.
Saddle Brook,  NY  07662
Correspondent Contact CEURREMANS
Regulation Number886.5844
Classification Product Code
HQG  
Date Received11/06/1984
Decision Date 11/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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