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FDA 510(k)

DYNAREX NON-WOVEN SPONGE

K-Number: K991695 · 1999-07-15

ApplicantDynarex Corp.
Decision Date1999-07-15
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DYNAREX NON-WOVEN SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corp.. It received FDA 510(k) clearance on 1999-07-15 under 510(k) number K991695. 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 DYNAREX NON-WOVEN SPONGE?

DYNAREX NON-WOVEN SPONGE is a medical device that received FDA 510(k) clearance on 1999-07-15. The listed applicant is Dynarex Corp.. The 510(k) number is K991695.

When did DYNAREX NON-WOVEN SPONGE receive FDA 510(k) clearance?

DYNAREX NON-WOVEN SPONGE received FDA 510(k) clearance on 1999-07-15, under 510(k) number K991695.

Who is the listed applicant for DYNAREX NON-WOVEN SPONGE?

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

What is the FDA product code for DYNAREX NON-WOVEN SPONGE?

The FDA product code for DYNAREX NON-WOVEN SPONGE is KMF.

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Other records listing Dynarex Corp. 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.

K052743DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921K052314DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGEK012816DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414K012957TOWEL DRAPE, MODELS 4409, 4410K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-BK991694DYNAREX DRAIN SPONGE

View all 19 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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