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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact, Polymethylmethacrylate, Diagnostic
510(k) Number K051103
Device Name HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
Applicant
Haag-Streit USA, Inc.
7361 Calhoun Pl., Suite 500
Rockville,  MD  20855
Applicant Contact EDUARDO MARCH
Correspondent
Haag-Streit USA, Inc.
7361 Calhoun Pl., Suite 500
Rockville,  MD  20855
Correspondent Contact EDUARDO MARCH
Regulation Number886.1385
Classification Product Code
HJK  
Date Received04/29/2005
Decision Date 06/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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