FDA 510(k)

COLO-TAPE

K-Number: K791146 · 1979-07-30

ApplicantSuburban Ostomy Supply Co., Inc.

Decision Date1979-07-30

Product CodeEZR

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

COLO-TAPE is the device name listed in this FDA 510(k) record. The listed applicant is Suburban Ostomy Supply Co., Inc.. It received FDA 510(k) clearance on 1979-07-30 under 510(k) number K791146. The device is classified under product code EZR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLO-TAPE?

COLO-TAPE is a medical device that received FDA 510(k) clearance on 1979-07-30. The listed applicant is Suburban Ostomy Supply Co., Inc.. The 510(k) number is K791146.

When did COLO-TAPE receive FDA 510(k) clearance?

COLO-TAPE received FDA 510(k) clearance on 1979-07-30, under 510(k) number K791146.

Who is the listed applicant for COLO-TAPE?

The FDA 510(k) record lists Suburban Ostomy Supply Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLO-TAPE?

The FDA product code for COLO-TAPE is EZR.

Related Devices (Code: EZR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K844341UNITED SKIN BARRIER PASTEHowmedica Corp.K803100STOMAHESIVE PASTE PROTECTIVE SKIN BARRE. R. Squibb & Sons, Inc.K761340OSTOMY KARAYA GUM POWDERHowmedica Corp.K770230KARAYA GUM POWDERAtlantic Surgical K761319KARAYA GUM PRODUCTS - PROCESS CHANGEHowmedica Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.