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FDA 510(k)

PR CREAM

K-Number: K093159 · 2010-06-24

ApplicantPrugen IP Holdings, Inc.
Decision Date2010-06-24
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PR CREAM 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 2010-06-24 under 510(k) number K093159. 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 PR CREAM?

PR CREAM is a medical device that received FDA 510(k) clearance on 2010-06-24. The listed applicant is Prugen IP Holdings, Inc.. The 510(k) number is K093159.

When did PR CREAM receive FDA 510(k) clearance?

PR CREAM received FDA 510(k) clearance on 2010-06-24, under 510(k) number K093159.

Who is the listed applicant for PR CREAM?

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 PR CREAM?

The FDA product code for PR CREAM is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Prugen IP Holdings, 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.

K113774HPR PLUS EMOLLIENT FOAMK113772HPR EMOLLIENT FOAMK110732EMULSION SBK093156PRUCLAIR NONSTEROIDAL CREAMK092878PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE

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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