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FDA 510(k)

KOLPEXIN SPHERE

K-Number: K032644 · 2004-05-28

ApplicantAdamed , Ltd.
Decision Date2004-05-28
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KOLPEXIN SPHERE is the device name listed in this FDA 510(k) record. The listed applicant is Adamed , Ltd.. It received FDA 510(k) clearance on 2004-05-28 under 510(k) number K032644. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOLPEXIN SPHERE?

KOLPEXIN SPHERE is a medical device that received FDA 510(k) clearance on 2004-05-28. The listed applicant is Adamed , Ltd.. The 510(k) number is K032644.

When did KOLPEXIN SPHERE receive FDA 510(k) clearance?

KOLPEXIN SPHERE received FDA 510(k) clearance on 2004-05-28, under 510(k) number K032644.

Who is the listed applicant for KOLPEXIN SPHERE?

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

What is the FDA product code for KOLPEXIN SPHERE?

The FDA product code for KOLPEXIN SPHERE is HHW.

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Related Devices (Code: HHW)

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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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