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FDA 510(k)

RUFF WORK EYEGEAR

K-Number: K972717 · 1997-08-25

ApplicantRuff House, Inc.
Decision Date1997-08-25
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RUFF WORK EYEGEAR is the device name listed in this FDA 510(k) record. The listed applicant is Ruff House, Inc.. It received FDA 510(k) clearance on 1997-08-25 under 510(k) number K972717. 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 RUFF WORK EYEGEAR?

RUFF WORK EYEGEAR is a medical device that received FDA 510(k) clearance on 1997-08-25. The listed applicant is Ruff House, Inc.. The 510(k) number is K972717.

When did RUFF WORK EYEGEAR receive FDA 510(k) clearance?

RUFF WORK EYEGEAR received FDA 510(k) clearance on 1997-08-25, under 510(k) number K972717.

Who is the listed applicant for RUFF WORK EYEGEAR?

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

What is the FDA product code for RUFF WORK EYEGEAR?

The FDA product code for RUFF WORK EYEGEAR is HQY.

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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.

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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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