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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Solution, Ultrasonic Cleaners For Lenses
510(k) Number K902920
Device Name TURBOTRON 20/20
Applicant
Prestige Manufacturing Snd Bhd
Pruneyard Towers I
1901 S. Bascom, Suite 1390
Campbell,  CA  95008
Applicant Contact HENRY W JENDRICKS
Correspondent
Prestige Manufacturing Snd Bhd
Pruneyard Towers I
1901 S. Bascom, Suite 1390
Campbell,  CA  95008
Correspondent Contact HENRY W JENDRICKS
Regulation Number886.5928
Classification Product Code
LYL  
Date Received07/03/1990
Decision Date 10/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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