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FDA 510(k)

CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON

K-Number: K802677 · 1980-11-12

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1980-11-12
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802677. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON?

CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K802677.

When did CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON receive FDA 510(k) clearance?

CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802677.

Who is the listed applicant for CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON?

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

What is the FDA product code for CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON?

The FDA product code for CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON is EXB.

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Related Devices (Code: EXB)

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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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