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FDA 510(k)

INFPUMP INFILTRATION PUMP

K-Number: K050324 · 2005-04-27

ApplicantCarolina Medical, Inc.
Decision Date2005-04-27
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFPUMP INFILTRATION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Medical, Inc.. It received FDA 510(k) clearance on 2005-04-27 under 510(k) number K050324. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFPUMP INFILTRATION PUMP?

INFPUMP INFILTRATION PUMP is a medical device that received FDA 510(k) clearance on 2005-04-27. The listed applicant is Carolina Medical, Inc.. The 510(k) number is K050324.

When did INFPUMP INFILTRATION PUMP receive FDA 510(k) clearance?

INFPUMP INFILTRATION PUMP received FDA 510(k) clearance on 2005-04-27, under 510(k) number K050324.

Who is the listed applicant for INFPUMP INFILTRATION PUMP?

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

What is the FDA product code for INFPUMP INFILTRATION PUMP?

The FDA product code for INFPUMP INFILTRATION PUMP is FRN.

Related Clinical Trials

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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Other records listing Carolina 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.

K993978PR3 ULTRASOUND SYSTEM

Related Devices (Code: FRN)

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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