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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 K942750
Device Name SPECTACLE FRAMES
Applicant
Aspex Eyewear, Inc.
10-2 Dubon Ct.
Farmingdale,  NY  11735
Applicant Contact REGULATORY AFFAIRS PERSON
Correspondent
Aspex Eyewear, Inc.
10-2 Dubon Ct.
Farmingdale,  NY  11735
Correspondent Contact REGULATORY AFFAIRS PERSON
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received06/10/1994
Decision Date 07/25/1994
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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