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FDA 510(k)

PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM

K-Number: K112458 · 2012-01-05

ApplicantMedica-Rents Co., Ltd.
Decision Date2012-01-05
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medica-Rents Co., Ltd.. It received FDA 510(k) clearance on 2012-01-05 under 510(k) number K112458. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM?

PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-05. The listed applicant is Medica-Rents Co., Ltd.. The 510(k) number is K112458.

When did PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM receive FDA 510(k) clearance?

PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM received FDA 510(k) clearance on 2012-01-05, under 510(k) number K112458.

Who is the listed applicant for PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM?

The FDA 510(k) record lists Medica-Rents Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM?

The FDA product code for PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM is OMP.

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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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