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FDA 510(k)

THERA-CREAM, MODEL TCT004

K-Number: K032239 · 2004-07-30

ApplicantPrizm Medical, Inc.
Decision Date2004-07-30
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THERA-CREAM, MODEL TCT004 is the device name listed in this FDA 510(k) record. The listed applicant is Prizm Medical, Inc.. It received FDA 510(k) clearance on 2004-07-30 under 510(k) number K032239. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERA-CREAM, MODEL TCT004?

THERA-CREAM, MODEL TCT004 is a medical device that received FDA 510(k) clearance on 2004-07-30. The listed applicant is Prizm Medical, Inc.. The 510(k) number is K032239.

When did THERA-CREAM, MODEL TCT004 receive FDA 510(k) clearance?

THERA-CREAM, MODEL TCT004 received FDA 510(k) clearance on 2004-07-30, under 510(k) number K032239.

Who is the listed applicant for THERA-CREAM, MODEL TCT004?

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

What is the FDA product code for THERA-CREAM, MODEL TCT004?

The FDA product code for THERA-CREAM, MODEL TCT004 is GYB.

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Other records listing Prizm Medical, 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.

K0331225000Z SYSTEM (OTC)K024181PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEMK012974PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007K951727Z-WATCH SYSTEMK944487ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODESK932299ELECTRO-MESH

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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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