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FDA 510(k)

BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)

K-Number: K980741 · 1998-05-11

ApplicantPolymer Technology Div. Wilmington Partners, L.P.
Decision Date1998-05-11
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Div. Wilmington Partners, L.P.. It received FDA 510(k) clearance on 1998-05-11 under 510(k) number K980741. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)?

BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) is a medical device that received FDA 510(k) clearance on 1998-05-11. The listed applicant is Polymer Technology Div. Wilmington Partners, L.P.. The 510(k) number is K980741.

When did BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) receive FDA 510(k) clearance?

BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) received FDA 510(k) clearance on 1998-05-11, under 510(k) number K980741.

Who is the listed applicant for BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)?

The FDA 510(k) record lists Polymer Technology Div. Wilmington Partners, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)?

The FDA product code for BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) is HQD.

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Other records listing Polymer Technology Div. Wilmington Partners, L.P. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983836RIGID GAS PERMEABLE CONTACT LENS SOLUTIONK962512BOSTON CONTACT LENS CASE

Related Devices (Code: HQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A BostonsightK240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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