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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Frame, Spectacle
510(k) Number K941414
Device Name EYECOTECH CORP
Applicant
Eyecotech Corp.
2729 S. Pepperdale Dr.
Rowland Heights,  CA  91748
Applicant Contact JENNIFER KUO
Correspondent
Eyecotech Corp.
2729 S. Pepperdale Dr.
Rowland Heights,  CA  91748
Correspondent Contact JENNIFER KUO
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received03/23/1994
Decision Date 07/12/1994
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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