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FDA 510(k)

BREAST BOLSTER

K-Number: K020624 · 2002-09-12

ApplicantBeekley Corp.
Decision Date2002-09-12
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BREAST BOLSTER is the device name listed in this FDA 510(k) record. The listed applicant is Beekley Corp.. It received FDA 510(k) clearance on 2002-09-12 under 510(k) number K020624. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREAST BOLSTER?

BREAST BOLSTER is a medical device that received FDA 510(k) clearance on 2002-09-12. The listed applicant is Beekley Corp.. The 510(k) number is K020624.

When did BREAST BOLSTER receive FDA 510(k) clearance?

BREAST BOLSTER received FDA 510(k) clearance on 2002-09-12, under 510(k) number K020624.

Who is the listed applicant for BREAST BOLSTER?

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

What is the FDA product code for BREAST BOLSTER?

The FDA product code for BREAST BOLSTER is IZH.

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.

Other records listing Beekley 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.

Related Devices (Code: IZH)

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.

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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