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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 K832175
Device Name DIGILAB 350 THE KRAKAU PERIMETER
Applicant
BIO-RAD
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIO-RAD
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.1605
Classification Product Code
HPT  
Date Received07/06/1983
Decision Date 08/16/1983
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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