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FDA 510(k), K974837, IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
FDA 510(k), K974837, IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
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$149.00 USD
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510(K) Number: K974837
Device Name: IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
Manufacturer: JOHN M SZABOCSIK
Device Classification Name: Lenses, Soft Contact, Daily Wear
Regulation Number: LPL
Classification Product Code: 12/24/1997
Date Received: 07/06/1998
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
Manufacturer: JOHN M SZABOCSIK
Device Classification Name: Lenses, Soft Contact, Daily Wear
Regulation Number: LPL
Classification Product Code: 12/24/1997
Date Received: 07/06/1998
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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