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FDA 510(k)

HYPERGEL PROTECTIVE WOUND GEL

K-Number: K905439 · 1991-05-29

ApplicantScott Health Care
Decision Date1991-05-29
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYPERGEL PROTECTIVE WOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is Scott Health Care. It received FDA 510(k) clearance on 1991-05-29 under 510(k) number K905439. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERGEL PROTECTIVE WOUND GEL?

HYPERGEL PROTECTIVE WOUND GEL is a medical device that received FDA 510(k) clearance on 1991-05-29. The listed applicant is Scott Health Care. The 510(k) number is K905439.

When did HYPERGEL PROTECTIVE WOUND GEL receive FDA 510(k) clearance?

HYPERGEL PROTECTIVE WOUND GEL received FDA 510(k) clearance on 1991-05-29, under 510(k) number K905439.

Who is the listed applicant for HYPERGEL PROTECTIVE WOUND GEL?

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

What is the FDA product code for HYPERGEL PROTECTIVE WOUND GEL?

The FDA product code for HYPERGEL PROTECTIVE WOUND GEL is KMF.

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Other records listing Scott Health Care 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.

K954275MEPORE PLUS (9X15CM)K954274MEPORE (6X7)K945206ALLDRESS MULTI LAYERED WOUND DRESSINGK932743MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATIONK910857ALLDRESS MULTI LAYERED WOUND DRESSINGK905438NORMLGEL PROTECTIVE WOUND GEL

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Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, 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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