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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 K971795
Device Name AUTOMATED CHAMBER MAINTENANCE MODULE
Applicant
PARADIGM MEDICAL INDUSTRIES, INC.
1772 WEST 2300 SOUTH
SALT LAKE CITY,  UT  84119
Applicant Contact RICHARD DIRKSON
Correspondent
PARADIGM MEDICAL INDUSTRIES, INC.
1772 WEST 2300 SOUTH
SALT LAKE CITY,  UT  84119
Correspondent Contact RICHARD DIRKSON
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/15/1997
Decision Date 07/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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