FDA 510(k) Application Details - K910707

Device Classification Name Sponge, Ophthalmic

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510(K) Number K910707
Device Name Sponge, Ophthalmic
Applicant JEDMED INSTRUMENT CO.
6096 LEMAY FERRY RD.
ST.LOUIS, MO US
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Contact CRAIG RAPP
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Regulation Number 886.4790

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Classification Product Code HOZ
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Date Received 02/20/1991
Decision Date 04/10/1991
Decision SE - Substantially Equivalent
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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