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FDA 510(k)

OSTOMY APPLIANCE BELT

K-Number: K781088 · 1978-08-18

ApplicantE. R. Squibb & Sons, Inc.
Decision Date1978-08-18
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OSTOMY APPLIANCE BELT 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 1978-08-18 under 510(k) number K781088. 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 APPLIANCE BELT?

OSTOMY APPLIANCE BELT is a medical device that received FDA 510(k) clearance on 1978-08-18. The listed applicant is E. R. Squibb & Sons, Inc.. The 510(k) number is K781088.

When did OSTOMY APPLIANCE BELT receive FDA 510(k) clearance?

OSTOMY APPLIANCE BELT received FDA 510(k) clearance on 1978-08-18, under 510(k) number K781088.

Who is the listed applicant for OSTOMY APPLIANCE BELT?

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 OSTOMY APPLIANCE BELT?

The FDA product code for OSTOMY APPLIANCE BELT is EXB.

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

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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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