FDA 510(k)

C.O.L.D.A.

K-Number: K963630 · 1996-10-18

Decision Date1996-10-18

Product CodeHQY

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

C.O.L.D.A. is the device name listed in this FDA 510(k) record. The listed applicant is C.O.L.D.A. S.N.C.. It received FDA 510(k) clearance on 1996-10-18 under 510(k) number K963630. 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 C.O.L.D.A.?

C.O.L.D.A. is a medical device that received FDA 510(k) clearance on 1996-10-18. The listed applicant is C.O.L.D.A. S.N.C.. The 510(k) number is K963630.

When did C.O.L.D.A. receive FDA 510(k) clearance?

C.O.L.D.A. received FDA 510(k) clearance on 1996-10-18, under 510(k) number K963630.

Who is the listed applicant for C.O.L.D.A.?

The FDA 510(k) record lists C.O.L.D.A. S.N.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C.O.L.D.A.?

The FDA product code for C.O.L.D.A. is HQY.

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

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