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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prism, gonioscopic
510(k) Number K862024
Device Name SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM
Applicant
OCULAR INSTRUMENTS, INC.
12100 NORTHUP WAY
SUITE D
BELLEVUE,  WA  98005
Applicant Contact TAMSIN J ERICKSON
Correspondent
OCULAR INSTRUMENTS, INC.
12100 NORTHUP WAY
SUITE D
BELLEVUE,  WA  98005
Correspondent Contact TAMSIN J ERICKSON
Regulation Number886.1660
Classification Product Code
HKS  
Date Received05/28/1986
Decision Date 07/11/1986
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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