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FDA 510(k)

72 HOUR USE TRACH CARE WITH MICROBAN

K-Number: K974630 · 1998-03-11

ApplicantBallard Medical Products
Decision Date1998-03-11
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

72 HOUR USE TRACH CARE WITH MICROBAN is the device name listed in this FDA 510(k) record. The listed applicant is Ballard Medical Products. It received FDA 510(k) clearance on 1998-03-11 under 510(k) number K974630. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 72 HOUR USE TRACH CARE WITH MICROBAN?

72 HOUR USE TRACH CARE WITH MICROBAN is a medical device that received FDA 510(k) clearance on 1998-03-11. The listed applicant is Ballard Medical Products. The 510(k) number is K974630.

When did 72 HOUR USE TRACH CARE WITH MICROBAN receive FDA 510(k) clearance?

72 HOUR USE TRACH CARE WITH MICROBAN received FDA 510(k) clearance on 1998-03-11, under 510(k) number K974630.

Who is the listed applicant for 72 HOUR USE TRACH CARE WITH MICROBAN?

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

What is the FDA product code for 72 HOUR USE TRACH CARE WITH MICROBAN?

The FDA product code for 72 HOUR USE TRACH CARE WITH MICROBAN is CAH.

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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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