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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Clip, Tantalum, Ophthalmic
510(k) Number K901275
Device Name RETINAL TAAK
Applicant
Alcon Surgical, Inc.
17701 Cowan Ave.
Irvine,  CA  92713
Applicant Contact DAVE KRAPF
Correspondent
Alcon Surgical, Inc.
17701 Cowan Ave.
Irvine,  CA  92713
Correspondent Contact DAVE KRAPF
Regulation Number886.3100
Classification Product Code
HQW  
Date Received03/19/1990
Decision Date 03/23/1990
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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