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FDA 510(k) Application Details - K091240
Device Classification Name
Sponge, Ophthalmic
More FDA Info for this Device
510(K) Number
K091240
Device Name
Sponge, Ophthalmic
Applicant
ALPHAMED INC.
3912 MOUNTAIN AVE.
EL PASO, TX 79930 US
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Contact
JAMES GUBACHY
Other 510(k) Applications for this Contact
Regulation Number
886.4790
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Classification Product Code
HOZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/27/2009
Decision Date
10/23/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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