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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chart, Visual Acuity
510(k) Number K944156
Device Name HEINE LAMBDA 100
Applicant
Heine USA , Ltd.
3500 Regency Pkwy. Suite"C"
Cary,  NC  27511
Applicant Contact BEN S JEAN
Correspondent
Heine USA , Ltd.
3500 Regency Pkwy. Suite"C"
Cary,  NC  27511
Correspondent Contact BEN S JEAN
Regulation Number886.1150
Classification Product Code
HOX  
Date Received08/26/1994
Decision Date 01/12/1995
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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