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510(k) Data Aggregation
K Number
K983836Device Name
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
Manufacturer
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
Date Cleared
1999-02-11
(104 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Boston® Enhanced Original Formula Conditioning Solution is indicated for use in wetting, disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.
Device Description
The modified Boston® Enhanced Original Formula Conditioning Solution is a sterile conditioning solution used in the care of rigid gas permeable contact lenses and is indicated for the wetting, disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate and silicone acrylate contact lenses. This product is a sterile, buffered solution, preserved with chlorhexidine gluconate and edetate disodium.
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K Number
K980741Device Name
BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)
Manufacturer
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
Date Cleared
1998-05-11
(74 days)
Product Code
HQD
Regulation Number
886.5916Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BOSTON EO (enflufocon B) Contact Lens Material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.
Device Description
The BOSTON EO Gas Permeable Contact Lens Material, enflufocon B, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber (Uvinul D-49). The color additives conform with 21 CFR part 74.3206. The enflufocon B material has an oxygen permeability, DK, of 58, a specific gravity of 1.23, and the lens visible light transmittance of at least 70%. The enflufocon B name has been adopted by the United States Adopted Names Council (USAN).
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K Number
K962512Device Name
BOSTON CONTACT LENS CASE
Manufacturer
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
Date Cleared
1996-07-12
(15 days)
Product Code
LRX
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BOSTON Contact Lens Case is indicated for disinfection and storage of rigid gas permeable contact lenses.
Device Description
The BOSTON® Contact Lens Case is plastic and double-welled with ridged screw caps on the wells. The interiors of the wells and caps contain elevated ridges to prevent the adherence of rigid gas permeable contact lenses to the surfaces.
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