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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sponge, ophthalmic
510(k) Number K082460
Device Name CENEFOM PVA SURGICAL SPEAR
Applicant
LONGTEK SCIENTIFIC CO., LTD.
7128 STAFFORDSHIRE ST.
HOUSTON,  TX  77030
Applicant Contact JOSEPH J CHANG
Correspondent
LONGTEK SCIENTIFIC CO., LTD.
7128 STAFFORDSHIRE ST.
HOUSTON,  TX  77030
Correspondent Contact JOSEPH J CHANG
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received08/26/2008
Decision Date 12/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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