FDA 510(k)

TRACHEOSTOMY CARE KIT

K-Number: K910362 · 1991-04-08

ApplicantMegadyne Medical Products, Inc.

Decision Date1991-04-08

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TRACHEOSTOMY CARE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 1991-04-08 under 510(k) number K910362. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHEOSTOMY CARE KIT?

TRACHEOSTOMY CARE KIT is a medical device that received FDA 510(k) clearance on 1991-04-08. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K910362.

When did TRACHEOSTOMY CARE KIT receive FDA 510(k) clearance?

TRACHEOSTOMY CARE KIT received FDA 510(k) clearance on 1991-04-08, under 510(k) number K910362.

Who is the listed applicant for TRACHEOSTOMY CARE KIT?

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

What is the FDA product code for TRACHEOSTOMY CARE KIT?

The FDA product code for TRACHEOSTOMY CARE KIT is JOH.

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Other records listing Megadyne Medical Products, Inc. as applicant

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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.