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FDA 510(k)

KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING

K-Number: K033453 · 2004-04-29

ApplicantTyco Healthcare
Decision Date2004-04-29
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare. It received FDA 510(k) clearance on 2004-04-29 under 510(k) number K033453. 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 KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING?

KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING is a medical device that received FDA 510(k) clearance on 2004-04-29. The listed applicant is Tyco Healthcare. The 510(k) number is K033453.

When did KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING receive FDA 510(k) clearance?

KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING received FDA 510(k) clearance on 2004-04-29, under 510(k) number K033453.

Who is the listed applicant for KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING?

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

What is the FDA product code for KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING?

The FDA product code for KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Tyco Healthcare 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.

K071049DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSORK070685KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662K070653KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662K061492MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGEK042709DOVER SILVER TEMPERATURE SENSING FOLEY CATHETERK040897DOVER ROB-NEL CATHETER

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Related Devices (Code: FRO)

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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