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FDA 510(k)

GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT

K-Number: K890107 · 1989-10-24

ApplicantPremium Plastics, Inc.
Decision Date1989-10-24
Product CodeFRO
DecisionUnknown

Device Summary

GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plastics, Inc.. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K890107. 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: Unknown.

Frequently Asked Questions

What is the GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT?

GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Premium Plastics, Inc.. The 510(k) number is K890107.

When did GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT receive FDA 510(k) clearance?

GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT received FDA 510(k) clearance on 1989-10-24, under 510(k) number K890107.

Who is the listed applicant for GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT?

The FDA 510(k) record lists Premium Plastics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT?

The FDA product code for GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT is FRO. This falls under the Anesthesiology category.

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Other records listing Premium Plastics, Inc. as applicant

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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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