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FDA 510(k)

SPYROGEL HYDROGEL WOUND AND BURN DRESSING

K-Number: K982804 · 1998-12-16

ApplicantInnovative Technologies (Us), Inc.
Decision Date1998-12-16
Product CodeMGQ
DecisionSubstantially Equivalent for Some Indications

Device Summary

SPYROGEL HYDROGEL WOUND AND BURN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Technologies (Us), Inc.. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K982804. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SPYROGEL HYDROGEL WOUND AND BURN DRESSING?

SPYROGEL HYDROGEL WOUND AND BURN DRESSING is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Innovative Technologies (Us), Inc.. The 510(k) number is K982804.

When did SPYROGEL HYDROGEL WOUND AND BURN DRESSING receive FDA 510(k) clearance?

SPYROGEL HYDROGEL WOUND AND BURN DRESSING received FDA 510(k) clearance on 1998-12-16, under 510(k) number K982804.

Who is the listed applicant for SPYROGEL HYDROGEL WOUND AND BURN DRESSING?

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

What is the FDA product code for SPYROGEL HYDROGEL WOUND AND BURN DRESSING?

The FDA product code for SPYROGEL HYDROGEL WOUND AND BURN DRESSING is MGQ.

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Other records listing Innovative Technologies (Us), 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.

K980673SPYROSORB FOAM ISLAND WOUND DRESSINGK974520SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM

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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