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FDA 510(k)

VITALA CONTINENCE CONTROL DEVICE

K-Number: K111365 · 2011-08-19

ApplicantConvatec, Inc.
Decision Date2011-08-19
Product CodeEZQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VITALA CONTINENCE CONTROL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, Inc.. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K111365. The device is classified under product code EZQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALA CONTINENCE CONTROL DEVICE?

VITALA CONTINENCE CONTROL DEVICE is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Convatec, Inc.. The 510(k) number is K111365.

When did VITALA CONTINENCE CONTROL DEVICE receive FDA 510(k) clearance?

VITALA CONTINENCE CONTROL DEVICE received FDA 510(k) clearance on 2011-08-19, under 510(k) number K111365.

Who is the listed applicant for VITALA CONTINENCE CONTROL DEVICE?

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

What is the FDA product code for VITALA CONTINENCE CONTROL DEVICE?

The FDA product code for VITALA CONTINENCE CONTROL DEVICE is EZQ.

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Other records listing Convatec, Inc. as applicant

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Related Devices (Code: EZQ)

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.

K102536VITALA CONTINENCE CONTROL DEVICEConvatec, Inc.K083785VITALA CONTINENCE CONTROL DEVICEConvatecK9224014 SURE TM COLOSTOMY POUCHBoston Pacific Medical, Inc.K880327MARLEN ULTRA ILEOSTOMY POUCH-5000Marlen Mfg. & Development Co.K863830CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEMColoplast A/S

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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