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FDA 510(k)

SWEEN WOUN'DRES

K-Number: K983042 · 1998-11-25

ApplicantColoplast Corp.
Decision Date1998-11-25
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

SWEEN WOUN'DRES is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K983042. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWEEN WOUN'DRES?

SWEEN WOUN'DRES is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Coloplast Corp.. The 510(k) number is K983042.

When did SWEEN WOUN'DRES receive FDA 510(k) clearance?

SWEEN WOUN'DRES received FDA 510(k) clearance on 1998-11-25, under 510(k) number K983042.

Who is the listed applicant for SWEEN WOUN'DRES?

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

What is the FDA product code for SWEEN WOUN'DRES?

The FDA product code for SWEEN WOUN'DRES is MGQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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