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FDA 510(k)

OSTOMY OR UROSTOMY ABDOMINAL BELT OS

K-Number: K842119 · 1984-09-10

ApplicantAtlas Surgical Belt Co., Inc.
Decision Date1984-09-10
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OSTOMY OR UROSTOMY ABDOMINAL BELT OS is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Surgical Belt Co., Inc.. It received FDA 510(k) clearance on 1984-09-10 under 510(k) number K842119. 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 OSTOMY OR UROSTOMY ABDOMINAL BELT OS?

OSTOMY OR UROSTOMY ABDOMINAL BELT OS is a medical device that received FDA 510(k) clearance on 1984-09-10. The listed applicant is Atlas Surgical Belt Co., Inc.. The 510(k) number is K842119.

When did OSTOMY OR UROSTOMY ABDOMINAL BELT OS receive FDA 510(k) clearance?

OSTOMY OR UROSTOMY ABDOMINAL BELT OS received FDA 510(k) clearance on 1984-09-10, under 510(k) number K842119.

Who is the listed applicant for OSTOMY OR UROSTOMY ABDOMINAL BELT OS?

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

What is the FDA product code for OSTOMY OR UROSTOMY ABDOMINAL BELT OS?

The FDA product code for OSTOMY OR UROSTOMY ABDOMINAL BELT OS is EXB.

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Related Devices (Code: EXB)

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.

K252140Heylo™ SystemColoplast Corp.K181643SmartBag (SmartPouch)11 Health Technologies LimitedK922730LAKE OSTOMY CARE SETLake Medical Products, Inc.K882878ODOR-END EMERGENCY CLEAN UP POWDERCdc Products Corp.K881636CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)Coloplast A/SK880306EMERGENCY-CLEAN UP(TM) ECPCdc Products Corp.

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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