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FDA 510(k)

HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING

K-Number: K941216 · 1994-05-20

ApplicantWilshire Medical Products
Decision Date1994-05-20
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Wilshire Medical Products. It received FDA 510(k) clearance on 1994-05-20 under 510(k) number K941216. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING?

HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING is a medical device that received FDA 510(k) clearance on 1994-05-20. The listed applicant is Wilshire Medical Products. The 510(k) number is K941216.

When did HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING receive FDA 510(k) clearance?

HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING received FDA 510(k) clearance on 1994-05-20, under 510(k) number K941216.

Who is the listed applicant for HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING?

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

What is the FDA product code for HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING?

The FDA product code for HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING is KMF.

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Other records listing Wilshire Medical Products 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.

K946030DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSINGK946031DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSINGK944333HYDRODERM GEL WOUND DRESSINGK941149DERMAASSIST HYDROCOLLOID DRESSINGK941005DERMASSIST(TM) XEROFORM PETROLATUM DRESSINGK940044DERMASSIST WET DRESSING, SALINE

View all 12 devices →

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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