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FDA 510(k)

MADEGOM LTDA. PENROSE DRAIN TUBING

K-Number: K894119 · 1989-08-18

ApplicantMadegom
Decision Date1989-08-18
Product CodeGBW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MADEGOM LTDA. PENROSE DRAIN TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Madegom. It received FDA 510(k) clearance on 1989-08-18 under 510(k) number K894119. The device is classified under product code GBW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MADEGOM LTDA. PENROSE DRAIN TUBING?

MADEGOM LTDA. PENROSE DRAIN TUBING is a medical device that received FDA 510(k) clearance on 1989-08-18. The listed applicant is Madegom. The 510(k) number is K894119.

When did MADEGOM LTDA. PENROSE DRAIN TUBING receive FDA 510(k) clearance?

MADEGOM LTDA. PENROSE DRAIN TUBING received FDA 510(k) clearance on 1989-08-18, under 510(k) number K894119.

Who is the listed applicant for MADEGOM LTDA. PENROSE DRAIN TUBING?

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

What is the FDA product code for MADEGOM LTDA. PENROSE DRAIN TUBING?

The FDA product code for MADEGOM LTDA. PENROSE DRAIN TUBING is GBW.

Related Clinical Trials

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.

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Other records listing Madegom 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.

K894120MADEGOM LTDA. DENTAL DAM

Related Devices (Code: GBW)

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.

K992907INTRADUCERTaut, Inc.K992904MINI-PORTTaut, Inc.K972112INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450Taut, Inc.K961194ANTIMICROBIAL MEDIASTINAL SILICONE DRAINSil-Med Corp.K960426MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETERMedical Components, Inc.K942709MEDIASTINAL SILICONE DRAINSSil-Med 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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