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FDA 510(k)

MARKWELL GAUZE SPONGE

K-Number: K982260 · 1998-08-12

ApplicantMarkwell Intl., Inc.
Decision Date1998-08-12
Product CodeLWH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MARKWELL GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Markwell Intl., Inc.. It received FDA 510(k) clearance on 1998-08-12 under 510(k) number K982260. The device is classified under product code LWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARKWELL GAUZE SPONGE?

MARKWELL GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1998-08-12. The listed applicant is Markwell Intl., Inc.. The 510(k) number is K982260.

When did MARKWELL GAUZE SPONGE receive FDA 510(k) clearance?

MARKWELL GAUZE SPONGE received FDA 510(k) clearance on 1998-08-12, under 510(k) number K982260.

Who is the listed applicant for MARKWELL GAUZE SPONGE?

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

What is the FDA product code for MARKWELL GAUZE SPONGE?

The FDA product code for MARKWELL GAUZE SPONGE is LWH.

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Related Devices (Code: LWH)

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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