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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratome, Ac-Powered
510(k) Number K041110
Device Name MB 105 MILLENNIUM BLADES
Applicant
Millennium Biomedical, Inc.
360 E. Bonita Ave.
Pomona,  CA  91767
Applicant Contact JERRY KAENI
Correspondent
Millennium Biomedical, Inc.
360 E. Bonita Ave.
Pomona,  CA  91767
Correspondent Contact JERRY KAENI
Regulation Number886.4370
Classification Product Code
HNO  
Date Received04/28/2004
Decision Date 10/13/2004
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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