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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoscope, Ac-Powered
510(k) Number K895741
Device Name CLAS PHOTOKERATOSCOPE
Applicant
Kera-Metrics Corp.
11211 Sorrento Valley Rd.,
Suite X
San Diego,  CA  92121
Applicant Contact RICHARD T SWANSON
Correspondent
Kera-Metrics Corp.
11211 Sorrento Valley Rd.,
Suite X
San Diego,  CA  92121
Correspondent Contact RICHARD T SWANSON
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received09/26/1989
Decision Date 07/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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