FDA 510(k)

CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE

K-Number: K002546 · 2000-10-31

ApplicantCIVCO Medical Instruments Co., Inc.

Decision Date2000-10-31

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 2000-10-31 under 510(k) number K002546. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE?

CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE is a medical device that received FDA 510(k) clearance on 2000-10-31. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K002546.

When did CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE receive FDA 510(k) clearance?

CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE received FDA 510(k) clearance on 2000-10-31, under 510(k) number K002546.

Who is the listed applicant for CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE?

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

What is the FDA product code for CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE?

The FDA product code for CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE is KNW.

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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.