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FDA 510(k)

DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414

K-Number: K012816 · 2002-10-17

ApplicantDynarex Corp.
Decision Date2002-10-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corp.. It received FDA 510(k) clearance on 2002-10-17 under 510(k) number K012816. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414?

DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 is a medical device that received FDA 510(k) clearance on 2002-10-17. The listed applicant is Dynarex Corp.. The 510(k) number is K012816.

When did DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 receive FDA 510(k) clearance?

DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 received FDA 510(k) clearance on 2002-10-17, under 510(k) number K012816.

Who is the listed applicant for DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414?

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 IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414?

The FDA product code for DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 is FRO. This falls under the Anesthesiology category.

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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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