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FDA 510(k)

Dynarex Xeroform Petrolatum Dressing

K-Number: K152970 · 2016-10-03

ApplicantDynarex Corporation
Decision Date2016-10-03
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Dynarex Xeroform Petrolatum Dressing is a medical device manufactured by Dynarex Corporation. It received FDA 510(k) clearance on 2016-10-03 under approval number K152970. 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 Xeroform Petrolatum Dressing?

Dynarex Xeroform Petrolatum Dressing is a medical device that received FDA 510(k) clearance on 2016-10-03. It is manufactured by Dynarex Corporation. The 510(k) number is K152970.

When was Dynarex Xeroform Petrolatum Dressing approved by the FDA?

Dynarex Xeroform Petrolatum Dressing received FDA 510(k) clearance on 2016-10-03, under approval number K152970.

What company makes Dynarex Xeroform Petrolatum Dressing?

Dynarex Xeroform Petrolatum Dressing is manufactured by Dynarex Corporation.

What is the FDA product code for Dynarex Xeroform Petrolatum Dressing?

The FDA product code for Dynarex Xeroform Petrolatum Dressing is FRO. This falls under the Anesthesiology category.

Other Devices by Dynarex Corporation

K172266Dynarex Three-Way Stopcock

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K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC K153565DONASORB SILVER WOUND DRESSINGVirchow Biotech Pvt, Ltd.

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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