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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K971950
Device Name INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER
Applicant
Infinitech, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Applicant Contact ALAN T BECKMAN
Correspondent
Infinitech, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Correspondent Contact ALAN T BECKMAN
Regulation Number886.4390
Classification Product Code
HQF  
Date Received05/28/1997
Decision Date 08/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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