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FDA 510(k)

DUAL FLEX NON-LATEX

K-Number: K905026 · 1991-12-18

ApplicantMmi, Inc.
Decision Date1991-12-18
Product CodeFGD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DUAL FLEX NON-LATEX is the device name listed in this FDA 510(k) record. The listed applicant is Mmi, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K905026. The device is classified under product code FGD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL FLEX NON-LATEX?

DUAL FLEX NON-LATEX is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Mmi, Inc.. The 510(k) number is K905026.

When did DUAL FLEX NON-LATEX receive FDA 510(k) clearance?

DUAL FLEX NON-LATEX received FDA 510(k) clearance on 1991-12-18, under 510(k) number K905026.

Who is the listed applicant for DUAL FLEX NON-LATEX?

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

What is the FDA product code for DUAL FLEX NON-LATEX?

The FDA product code for DUAL FLEX NON-LATEX is FGD.

Related Clinical Trials

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Other records listing Mmi, 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.

K860445CLAMP-N-CUTK842130G.I. CLEANSING KIT

Related Devices (Code: FGD)

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.

K223890NAJA Gastrointestinal CatheterChess Medical, Inc.K905574SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFFE-Z-Em, Inc.K904299SLIM LINE RETENT TIP W/SILICONE INFLATION CUFFE-Z-Em, Inc.K884379MAGLINTE ENTEROCLYSIS CATHETERLafayette Pharmacal, Inc.K872006DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFFMac Lee Medical Products

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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