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FDA 510(k)

SUR-FIT UROSTOMY POUCH & URINARY BAG

K-Number: K800495 · 1980-04-08

ApplicantE. R. Squibb & Sons, Inc.
Decision Date1980-04-08
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUR-FIT UROSTOMY POUCH & URINARY BAG is the device name listed in this FDA 510(k) record. The listed applicant is E. R. Squibb & Sons, Inc.. It received FDA 510(k) clearance on 1980-04-08 under 510(k) number K800495. 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 SUR-FIT UROSTOMY POUCH & URINARY BAG?

SUR-FIT UROSTOMY POUCH & URINARY BAG is a medical device that received FDA 510(k) clearance on 1980-04-08. The listed applicant is E. R. Squibb & Sons, Inc.. The 510(k) number is K800495.

When did SUR-FIT UROSTOMY POUCH & URINARY BAG receive FDA 510(k) clearance?

SUR-FIT UROSTOMY POUCH & URINARY BAG received FDA 510(k) clearance on 1980-04-08, under 510(k) number K800495.

Who is the listed applicant for SUR-FIT UROSTOMY POUCH & URINARY BAG?

The FDA 510(k) record lists E. R. Squibb & Sons, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUR-FIT UROSTOMY POUCH & URINARY BAG?

The FDA product code for SUR-FIT UROSTOMY POUCH & URINARY BAG is EXB.

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Other records listing E. R. Squibb & Sons, Inc. as applicant

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.

K821494RIA STAT 16K820616ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAYK820341CORTISOL-SQUIBB RADIOIMMUNOASSAY KITK820340T3 UPTAKE-SQUIBB DIAGNOSTIC KITK811240SUR-FIT LOOP OSTOMY O.R. SETK811239SUR-FIT DISPOSABLE CONVEX INSERT

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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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