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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pupillometer, ac-powered
510(k) Number K895609
Device Name PUPIL PATHWAY ANALYZER (PPA)
Applicant
PULSE MEDICAL INSTRUMENTS
130 MCCORMICK AVE.
STE 112
COSTA MESA,  CA  92626
Applicant Contact JUDY C LINDSTROM
Correspondent
PULSE MEDICAL INSTRUMENTS
130 MCCORMICK AVE.
STE 112
COSTA MESA,  CA  92626
Correspondent Contact JUDY C LINDSTROM
Regulation Number886.1700
Classification Product Code
HLG  
Date Received09/18/1989
Decision Date 11/02/1989
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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