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FDA 510(k)

NU-DERM HYDROCOLLOID DRESSING

K-Number: K890545 · 1989-03-23

ApplicantJohnson & Johnson Patient Care, Inc.
Decision Date1989-03-23
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

NU-DERM HYDROCOLLOID DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Patient Care, Inc.. It received FDA 510(k) clearance on 1989-03-23 under 510(k) number K890545. 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 for Some Indications.

Frequently Asked Questions

What is the NU-DERM HYDROCOLLOID DRESSING?

NU-DERM HYDROCOLLOID DRESSING is a medical device that received FDA 510(k) clearance on 1989-03-23. The listed applicant is Johnson & Johnson Patient Care, Inc.. The 510(k) number is K890545.

When did NU-DERM HYDROCOLLOID DRESSING receive FDA 510(k) clearance?

NU-DERM HYDROCOLLOID DRESSING received FDA 510(k) clearance on 1989-03-23, under 510(k) number K890545.

Who is the listed applicant for NU-DERM HYDROCOLLOID DRESSING?

The FDA 510(k) record lists Johnson & Johnson Patient Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NU-DERM HYDROCOLLOID DRESSING?

The FDA product code for NU-DERM HYDROCOLLOID DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Johnson & Johnson Patient Care, Inc. 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.

K895431JOHNSON & JOHNSON TUBE SECUREMENT DEVICEK892851ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVERK884749JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE

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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