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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 K863367
Device Name FORMALENS 2000
Applicant
VISION-SCIENCES, INC.
140 EAST DUARTE RD.
MONROVIA,  CA  91016
Applicant Contact HOWARD SILVERMAN
Correspondent
VISION-SCIENCES, INC.
140 EAST DUARTE RD.
MONROVIA,  CA  91016
Correspondent Contact HOWARD SILVERMAN
Regulation Number886.5844
Classification Product Code
HQG  
Date Received09/03/1986
Decision Date 09/26/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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