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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name perimeter, automatic, ac-powered
510(k) Number K922294
Device Name PERIKON PCL 90
Applicant
OPTIKON OFTALMOLOGIA SPA
12014 MILLRIDEGE CIRCLE
SANDY,  UT  84094
Applicant Contact CHARLES W HUTCHINS
Correspondent
OPTIKON OFTALMOLOGIA SPA
12014 MILLRIDEGE CIRCLE
SANDY,  UT  84094
Correspondent Contact CHARLES W HUTCHINS
Regulation Number886.1605
Classification Product Code
HPT  
Date Received05/15/1992
Decision Date 01/28/1993
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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