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FDA 510(k)

DAKOTA SMITH, NICOLE MILLER SUNGLASSES

K-Number: K965125 · 1997-03-19

ApplicantCalifornia Design Studio, Inc.
Decision Date1997-03-19
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DAKOTA SMITH, NICOLE MILLER SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is California Design Studio, Inc.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K965125. 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 DAKOTA SMITH, NICOLE MILLER SUNGLASSES?

DAKOTA SMITH, NICOLE MILLER SUNGLASSES is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is California Design Studio, Inc.. The 510(k) number is K965125.

When did DAKOTA SMITH, NICOLE MILLER SUNGLASSES receive FDA 510(k) clearance?

DAKOTA SMITH, NICOLE MILLER SUNGLASSES received FDA 510(k) clearance on 1997-03-19, under 510(k) number K965125.

Who is the listed applicant for DAKOTA SMITH, NICOLE MILLER SUNGLASSES?

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

What is the FDA product code for DAKOTA SMITH, NICOLE MILLER SUNGLASSES?

The FDA product code for DAKOTA SMITH, NICOLE MILLER SUNGLASSES is HQY.

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Related Devices (Code: HQY)

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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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