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FDA 510(k)

PERACIDIN DIALYZER REPROCESSING CONCENTRATE

K-Number: K962959 · 1998-06-05

ApplicantHdc Medical, Inc.
Decision Date1998-06-05
Product CodeMED
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PERACIDIN DIALYZER REPROCESSING CONCENTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Hdc Medical, Inc.. It received FDA 510(k) clearance on 1998-06-05 under 510(k) number K962959. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERACIDIN DIALYZER REPROCESSING CONCENTRATE?

PERACIDIN DIALYZER REPROCESSING CONCENTRATE is a medical device that received FDA 510(k) clearance on 1998-06-05. The listed applicant is Hdc Medical, Inc.. The 510(k) number is K962959.

When did PERACIDIN DIALYZER REPROCESSING CONCENTRATE receive FDA 510(k) clearance?

PERACIDIN DIALYZER REPROCESSING CONCENTRATE received FDA 510(k) clearance on 1998-06-05, under 510(k) number K962959.

Who is the listed applicant for PERACIDIN DIALYZER REPROCESSING CONCENTRATE?

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

What is the FDA product code for PERACIDIN DIALYZER REPROCESSING CONCENTRATE?

The FDA product code for PERACIDIN DIALYZER REPROCESSING CONCENTRATE is MED.

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Official Source

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