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FDA 510(k), K984523, IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k), K984523, IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS
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$49.00 USD
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$49.00 USD
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510(K) Number: K984523
Device Name: IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS
Manufacturer: JOHN M SZABOCSIK
Device Classification Name: Lenses, Soft Contact, Daily Wear
Regulation Number: LPL
Classification Product Code: KXA
Date Received: 12/21/1998
Decision Date: 02/16/1999
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS
Manufacturer: JOHN M SZABOCSIK
Device Classification Name: Lenses, Soft Contact, Daily Wear
Regulation Number: LPL
Classification Product Code: KXA
Date Received: 12/21/1998
Decision Date: 02/16/1999
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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