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FDA 510(k)

ORVIS POLARIZED BI-FOCALS

K-Number: K943131 · 1994-08-02

ApplicantThe Orvis Co., Inc.
Decision Date1994-08-02
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ORVIS POLARIZED BI-FOCALS is the device name listed in this FDA 510(k) record. The listed applicant is The Orvis Co., Inc.. It received FDA 510(k) clearance on 1994-08-02 under 510(k) number K943131. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORVIS POLARIZED BI-FOCALS?

ORVIS POLARIZED BI-FOCALS is a medical device that received FDA 510(k) clearance on 1994-08-02. The listed applicant is The Orvis Co., Inc.. The 510(k) number is K943131.

When did ORVIS POLARIZED BI-FOCALS receive FDA 510(k) clearance?

ORVIS POLARIZED BI-FOCALS received FDA 510(k) clearance on 1994-08-02, under 510(k) number K943131.

Who is the listed applicant for ORVIS POLARIZED BI-FOCALS?

The FDA 510(k) record lists The Orvis Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORVIS POLARIZED BI-FOCALS?

The FDA product code for ORVIS POLARIZED BI-FOCALS is HQY.

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Other records listing The Orvis Co., Inc. 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.

K950609ORVIS KEY WEST SUNGLASSESK943161ORVIS DRIVING GLASSESK942951ORVIS LIGHT WEIGHT POLARIZED CLIP-ONSK942952ORVIS WORLD FINEST POLARIZED CLIP ONSK941910SUNGLASSESK941751SUNGLASSES

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Related Devices (Code: HQY)

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.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

Official Source

View on FDA Database →

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

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