FDA 510(k)

BOSTON(R) 7 - 30(ENFLUFOCON A)

K-Number: K943177 · 1994-08-25

Decision Date1994-08-25

Product CodeHQD

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

BOSTON(R) 7 - 30(ENFLUFOCON A) is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Corp.. It received FDA 510(k) clearance on 1994-08-25 under 510(k) number K943177. 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(R) 7 - 30(ENFLUFOCON A)?

BOSTON(R) 7 - 30(ENFLUFOCON A) is a medical device that received FDA 510(k) clearance on 1994-08-25. The listed applicant is Polymer Technology Corp.. The 510(k) number is K943177.

When did BOSTON(R) 7 - 30(ENFLUFOCON A) receive FDA 510(k) clearance?

BOSTON(R) 7 - 30(ENFLUFOCON A) received FDA 510(k) clearance on 1994-08-25, under 510(k) number K943177.

Who is the listed applicant for BOSTON(R) 7 - 30(ENFLUFOCON A)?

The FDA 510(k) record lists Polymer Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSTON(R) 7 - 30(ENFLUFOCON A)?

The FDA product code for BOSTON(R) 7 - 30(ENFLUFOCON A) is HQD.

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Other records listing Polymer Technology Corp. as applicant

K011945RIGID GAS PERMEABLE CONTACT LENS SOLUTION K980133BAUSCH & LOMB WETTING AND SOAKING SOLUTION K974466BOSTON ADVANCE CLEANER K973217BOSTON LIQUID ENZYMATIC CLEANER K970698BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS K951552BOSTON CONTACT LENS CASE

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Related Devices (Code: HQD)

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 Bostonsight K240618Acuity 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.