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FDA 510(k)

POLYBONE GRANULE & BLOCK

K-Number: K082338 · 2008-10-16

ApplicantKyung Won Medical Co., Ltd.
Decision Date2008-10-16
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLYBONE GRANULE & BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Kyung Won Medical Co., Ltd.. It received FDA 510(k) clearance on 2008-10-16 under 510(k) number K082338. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYBONE GRANULE & BLOCK?

POLYBONE GRANULE & BLOCK is a medical device that received FDA 510(k) clearance on 2008-10-16. The listed applicant is Kyung Won Medical Co., Ltd.. The 510(k) number is K082338.

When did POLYBONE GRANULE & BLOCK receive FDA 510(k) clearance?

POLYBONE GRANULE & BLOCK received FDA 510(k) clearance on 2008-10-16, under 510(k) number K082338.

Who is the listed applicant for POLYBONE GRANULE & BLOCK?

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

What is the FDA product code for POLYBONE GRANULE & BLOCK?

The FDA product code for POLYBONE GRANULE & BLOCK is MQV.

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Other records listing Kyung Won Medical Co., Ltd. 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.

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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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