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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 K923415
Device Name DBA FOCAL CHANGE FRAMES
Applicant
Focal Change
120 W. Lancaster Ave.
Suite 301
Ardmore,  PA  19003
Applicant Contact ALVIN WEINBERG
Correspondent
Focal Change
120 W. Lancaster Ave.
Suite 301
Ardmore,  PA  19003
Correspondent Contact ALVIN WEINBERG
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/10/1992
Decision Date 10/13/1992
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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