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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 K001806
Device Name REFRACTIVE SURGERY BLADES
Applicant
MILLENNIUM BIOMEDICAL, INC.
360 EAST BONITA AVE.
POMONA,  CA  91767
Applicant Contact JERRY KAENI
Correspondent
MILLENNIUM BIOMEDICAL, INC.
360 EAST BONITA AVE.
POMONA,  CA  91767
Correspondent Contact JERRY KAENI
Regulation Number886.4370
Classification Product Code
HNO  
Date Received06/15/2000
Decision Date 09/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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