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FDA 510(k)

SPECTABLE FRAME - PRODESIGN SUN CLUB

K-Number: K844658 · 1984-12-11

ApplicantPro Design Intl. AS
Decision Date1984-12-11
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTABLE FRAME - PRODESIGN SUN CLUB is the device name listed in this FDA 510(k) record. The listed applicant is Pro Design Intl. AS. It received FDA 510(k) clearance on 1984-12-11 under 510(k) number K844658. The device is classified under product code HQZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTABLE FRAME - PRODESIGN SUN CLUB?

SPECTABLE FRAME - PRODESIGN SUN CLUB is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Pro Design Intl. AS. The 510(k) number is K844658.

When did SPECTABLE FRAME - PRODESIGN SUN CLUB receive FDA 510(k) clearance?

SPECTABLE FRAME - PRODESIGN SUN CLUB received FDA 510(k) clearance on 1984-12-11, under 510(k) number K844658.

Who is the listed applicant for SPECTABLE FRAME - PRODESIGN SUN CLUB?

The FDA 510(k) record lists Pro Design Intl. AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTABLE FRAME - PRODESIGN SUN CLUB?

The FDA product code for SPECTABLE FRAME - PRODESIGN SUN CLUB is HQZ.

Related Clinical Trials

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.

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Other records listing Pro Design Intl. AS 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.

K844657SPECTABLE FRAME MAGNIFYING BRILLETTE

Related Devices (Code: HQZ)

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.

K952597VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEWPoint of View Optical Outlet, Inc.K944313SPECTACLE FRAMESun Hing Optical Manufactory , Ltd.K945770OPTICAL FRAMESRamada Optics, Inc.K945392SPECTACLE FRAMESeo Han Corp., Ltd.K945176SPECTACLE FRAME OR EYEGLASS FRAMESOptipia Trading Co.K945350FRAME, SPECTACLESTaiwan Eva Industrial Co., Inc.

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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