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FDA 510(k)

EPITECH ISLAND DRESSINGS

K-Number: K971337 · 1997-07-09

ApplicantRynel, Ltd. Inc.
Decision Date1997-07-09
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EPITECH ISLAND DRESSINGS is the device name listed in this FDA 510(k) record. The listed applicant is Rynel, Ltd. Inc.. It received FDA 510(k) clearance on 1997-07-09 under 510(k) number K971337. 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 EPITECH ISLAND DRESSINGS?

EPITECH ISLAND DRESSINGS is a medical device that received FDA 510(k) clearance on 1997-07-09. The listed applicant is Rynel, Ltd. Inc.. The 510(k) number is K971337.

When did EPITECH ISLAND DRESSINGS receive FDA 510(k) clearance?

EPITECH ISLAND DRESSINGS received FDA 510(k) clearance on 1997-07-09, under 510(k) number K971337.

Who is the listed applicant for EPITECH ISLAND DRESSINGS?

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

What is the FDA product code for EPITECH ISLAND DRESSINGS?

The FDA product code for EPITECH ISLAND DRESSINGS is KMF.

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 Rynel, Ltd. 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.

K951909RYNEL MEDICAL FOAM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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