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FDA 510(k)

REFLECTIONS

K-Number: K973776 · 1997-11-21

ApplicantCdb Corp.
Decision Date1997-11-21
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REFLECTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Cdb Corp.. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K973776. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLECTIONS?

REFLECTIONS is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Cdb Corp.. The 510(k) number is K973776.

When did REFLECTIONS receive FDA 510(k) clearance?

REFLECTIONS received FDA 510(k) clearance on 1997-11-21, under 510(k) number K973776.

Who is the listed applicant for REFLECTIONS?

The FDA 510(k) record lists Cdb Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFLECTIONS?

The FDA product code for REFLECTIONS is DYW.

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Related PubMed Literature

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.

PMID: 38600418Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections.Therapeutic innovation & regulatory science ()PMID: 34243826Measuring Patient Preferences at the FDA Center for Devices and Radiological Health: Reflections and Projections.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research ()

Other records listing Cdb Corp. 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.

K934881REFLECTIONSK922499REFLECTIONS - CERAMIC DENTAL BRACKET

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Official Source

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