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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 (other material) - daily
510(k) Number K945955
Device Name ROSE K LENS
Applicant
ROSE K INTERNATIONAL LTD.
P.O. BOX 9307
HAMILTON,  NZ
Applicant Contact I JENNINGS
Correspondent
ROSE K INTERNATIONAL LTD.
P.O. BOX 9307
HAMILTON,  NZ
Correspondent Contact I JENNINGS
Regulation Number886.5916
Classification Product Code
HQD  
Date Received12/06/1994
Decision Date 02/07/1995
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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