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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 K091240
Device Name ALPHAMED SURGICAL SPEAR, MODEL 70-5000
Applicant
ALPHAMED INC.
3912 MOUNTAIN AVE.
EL PASO,  TX  79930
Applicant Contact JAMES GUBACHY
Correspondent
ALPHAMED INC.
3912 MOUNTAIN AVE.
EL PASO,  TX  79930
Correspondent Contact JAMES GUBACHY
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received04/27/2009
Decision Date 10/23/2009
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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