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FDA 510(k)

STERILE, FOLEY CATHETERS W/PTFE COAT

K-Number: K841678 · 1984-07-19

ApplicantAbco Dealers, Inc.
Decision Date1984-07-19
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERILE, FOLEY CATHETERS W/PTFE COAT is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1984-07-19 under 510(k) number K841678. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE, FOLEY CATHETERS W/PTFE COAT?

STERILE, FOLEY CATHETERS W/PTFE COAT is a medical device that received FDA 510(k) clearance on 1984-07-19. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K841678.

When did STERILE, FOLEY CATHETERS W/PTFE COAT receive FDA 510(k) clearance?

STERILE, FOLEY CATHETERS W/PTFE COAT received FDA 510(k) clearance on 1984-07-19, under 510(k) number K841678.

Who is the listed applicant for STERILE, FOLEY CATHETERS W/PTFE COAT?

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

What is the FDA product code for STERILE, FOLEY CATHETERS W/PTFE COAT?

The FDA product code for STERILE, FOLEY CATHETERS W/PTFE COAT is KOD.

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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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