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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Weights, Eyelid, External
510(k) Number K000127
Device Name KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
Applicant
Heinz Kurz GmbH Medizintechnik
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Applicant Contact DAGMAR MASER
Correspondent
Heinz Kurz GmbH Medizintechnik
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Correspondent Contact DAGMAR MASER
Regulation Number886.5700
Classification Product Code
MML  
Date Received01/18/2000
Decision Date 04/12/2000
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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