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FDA 510(k)

MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP

K-Number: K953516 · 1995-12-08

ApplicantYoav Gershoni
Decision Date1995-12-08
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Yoav Gershoni. It received FDA 510(k) clearance on 1995-12-08 under 510(k) number K953516. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP?

MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP is a medical device that received FDA 510(k) clearance on 1995-12-08. The listed applicant is Yoav Gershoni. The 510(k) number is K953516.

When did MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP receive FDA 510(k) clearance?

MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP received FDA 510(k) clearance on 1995-12-08, under 510(k) number K953516.

Who is the listed applicant for MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP?

The FDA 510(k) record lists Yoav Gershoni as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP?

The FDA product code for MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP is IRP.

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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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