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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K873825
Device Name GE LEXAN 144R 112
Applicant
Applied Laboratories, Inc.
3360 Commerce Park Dr.
Columbus,  IN  47201
Applicant Contact ANTHONY J MORAVEC
Correspondent
Applied Laboratories, Inc.
3360 Commerce Park Dr.
Columbus,  IN  47201
Correspondent Contact ANTHONY J MORAVEC
Regulation Number886.5928
Classification Product Code
LRX  
Date Received09/21/1987
Decision Date 03/24/1988
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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