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FDA 510(k)

PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE

K-Number: K092878 · 2010-01-15

ApplicantPrugen IP Holdings, Inc.
Decision Date2010-01-15
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Prugen IP Holdings, Inc.. It received FDA 510(k) clearance on 2010-01-15 under 510(k) number K092878. 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 PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE?

PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE is a medical device that received FDA 510(k) clearance on 2010-01-15. The listed applicant is Prugen IP Holdings, Inc.. The 510(k) number is K092878.

When did PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE receive FDA 510(k) clearance?

PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE received FDA 510(k) clearance on 2010-01-15, under 510(k) number K092878.

Who is the listed applicant for PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE?

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

What is the FDA product code for PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE?

The FDA product code for PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE is FRO. This falls under the Anesthesiology category.

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Other records listing Prugen IP Holdings, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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