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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 K923458
Device Name CONTACT LENS CASE
Applicant
Nomax, Inc.
31 Scudder Rd.
Sparta,  NJ  07871
Applicant Contact ANDREA FRIEDMAN
Correspondent
Nomax, Inc.
31 Scudder Rd.
Sparta,  NJ  07871
Correspondent Contact ANDREA FRIEDMAN
Regulation Number886.5928
Classification Product Code
LRX  
Date Received07/14/1992
Decision Date 05/12/1993
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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