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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K953447
Device Name PRECISIONIST THIRTY THOUSAND
Applicant
PARADIGM MEDICAL INDUSTRIES, INC.
1772 WEST 2300 SOUTH
SALT LAKE CITY,  UT  84119
Applicant Contact ROBERT MILAR
Correspondent
PARADIGM MEDICAL INDUSTRIES, INC.
1772 WEST 2300 SOUTH
SALT LAKE CITY,  UT  84119
Correspondent Contact ROBERT MILAR
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/17/1995
Decision Date 10/13/1995
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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