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FDA 510(k)

WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL

K-Number: K935203 · 1994-01-18

ApplicantRenaissance Medical, Inc.
Decision Date1994-01-18
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL 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 1994-01-18 under 510(k) number K935203. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL?

WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL is a medical device that received FDA 510(k) clearance on 1994-01-18. The listed applicant is Renaissance Medical, Inc.. The 510(k) number is K935203.

When did WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL receive FDA 510(k) clearance?

WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL received FDA 510(k) clearance on 1994-01-18, under 510(k) number K935203.

Who is the listed applicant for WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL?

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 WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL?

The FDA product code for WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL is MGQ.

Related Clinical Trials

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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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.

K933817ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSEK932973ROYL-DERM WOUND HYDROGEL DRESSINGK922815ROYL-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.

K171879HylaGuard Moisturizing CreamFounders Science Group, LLCK083024HYLATOPIC EMOLLIENT FOAMCollegium Pharmaceutical IncorporatedK041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONStiefel Laboratories, Inc.K041268SILVERSITE OR CALGITROLAdriK040019SILVERSEALNoble Fiber TechnologiesK040517TENDERWET ACTIVEMedline Industries, Inc.

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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