FDA 510(k)

BUTTON REPLACEMENT GASTROSTOMY DEVICE

K-Number: K904779 · 1991-01-18

Decision Date1991-01-18

Product CodeKGC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BUTTON REPLACEMENT GASTROSTOMY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1991-01-18 under 510(k) number K904779. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUTTON REPLACEMENT GASTROSTOMY DEVICE?

BUTTON REPLACEMENT GASTROSTOMY DEVICE is a medical device that received FDA 510(k) clearance on 1991-01-18. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K904779.

When did BUTTON REPLACEMENT GASTROSTOMY DEVICE receive FDA 510(k) clearance?

BUTTON REPLACEMENT GASTROSTOMY DEVICE received FDA 510(k) clearance on 1991-01-18, under 510(k) number K904779.

Who is the listed applicant for BUTTON REPLACEMENT GASTROSTOMY DEVICE?

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

What is the FDA product code for BUTTON REPLACEMENT GASTROSTOMY DEVICE?

The FDA product code for BUTTON REPLACEMENT GASTROSTOMY DEVICE is KGC.

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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.