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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name chart, visual acuity
510(k) Number K881358
Device Name PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM
Applicant
NEUROSCIENTIFIC CORP.
139 FLORIDA ST.
FARMINGDALE,  NY  11735
Applicant Contact ALAN P SCHWARTZ
Correspondent
NEUROSCIENTIFIC CORP.
139 FLORIDA ST.
FARMINGDALE,  NY  11735
Correspondent Contact ALAN P SCHWARTZ
Regulation Number886.1150
Classification Product Code
HOX  
Date Received03/31/1988
Decision Date 06/27/1988
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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