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FDA 510(k)

ROYL-DERM WOUND HYDROGEL DRESSING

K-Number: K932973 · 1994-01-10

ApplicantRenaissance Medical, Inc.
Decision Date1994-01-10
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

ROYL-DERM WOUND HYDROGEL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Renaissance Medical, Inc.. It received FDA 510(k) clearance on 1994-01-10 under 510(k) number K932973. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROYL-DERM WOUND HYDROGEL DRESSING?

ROYL-DERM WOUND HYDROGEL DRESSING is a medical device that received FDA 510(k) clearance on 1994-01-10. The listed applicant is Renaissance Medical, Inc.. The 510(k) number is K932973.

When did ROYL-DERM WOUND HYDROGEL DRESSING receive FDA 510(k) clearance?

ROYL-DERM WOUND HYDROGEL DRESSING received FDA 510(k) clearance on 1994-01-10, under 510(k) number K932973.

Who is the listed applicant for ROYL-DERM WOUND HYDROGEL DRESSING?

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

What is the FDA product code for ROYL-DERM WOUND HYDROGEL DRESSING?

The FDA product code for ROYL-DERM WOUND HYDROGEL DRESSING is MGQ.

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Other records listing Renaissance Medical, Inc. 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.

K935203WOUND HYDROGEL AND/OR STERILE WOUND HYDROGELK933817ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSEK922815ROYL-DERM WOUND HYDROGEL

Related Devices (Code: MGQ)

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

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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