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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name caliper, ophthalmic
510(k) Number K881094
Device Name KOI(TM) BLADE GAUGE, MODEL KOI-132
Applicant
COOPERVISION, INC.
COOPERVISION CILCO
3190 160TH AVENUE S.E.
BELLEVUE,  WA  98008
Applicant Contact THERESA N CORLETT
Correspondent
COOPERVISION, INC.
COOPERVISION CILCO
3190 160TH AVENUE S.E.
BELLEVUE,  WA  98008
Correspondent Contact THERESA N CORLETT
Regulation Number886.4350
Classification Product Code
HOE  
Date Received03/15/1988
Decision Date 04/01/1988
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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