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FDA 510(k)

TOWEL DRAPE, MODELS 4409, 4410

K-Number: K012957 · 2002-03-06

ApplicantDynarex Corp.
Decision Date2002-03-06
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOWEL DRAPE, MODELS 4409, 4410 is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corp.. It received FDA 510(k) clearance on 2002-03-06 under 510(k) number K012957. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOWEL DRAPE, MODELS 4409, 4410?

TOWEL DRAPE, MODELS 4409, 4410 is a medical device that received FDA 510(k) clearance on 2002-03-06. The listed applicant is Dynarex Corp.. The 510(k) number is K012957.

When did TOWEL DRAPE, MODELS 4409, 4410 receive FDA 510(k) clearance?

TOWEL DRAPE, MODELS 4409, 4410 received FDA 510(k) clearance on 2002-03-06, under 510(k) number K012957.

Who is the listed applicant for TOWEL DRAPE, MODELS 4409, 4410?

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 TOWEL DRAPE, MODELS 4409, 4410?

The FDA product code for TOWEL DRAPE, MODELS 4409, 4410 is KKX.

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Other records listing Dynarex Corp. as applicant

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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, 3414K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-BK991694DYNAREX DRAIN SPONGEK991695DYNAREX NON-WOVEN SPONGE

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Related Devices (Code: KKX)

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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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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