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FDA 510(k)

G.I. CLEANSING KIT

K-Number: K842130 · 1984-08-08

ApplicantMmi, Inc.
Decision Date1984-08-08
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

G.I. CLEANSING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mmi, Inc.. It received FDA 510(k) clearance on 1984-08-08 under 510(k) number K842130. The device is classified under product code FCE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G.I. CLEANSING KIT?

G.I. CLEANSING KIT is a medical device that received FDA 510(k) clearance on 1984-08-08. The listed applicant is Mmi, Inc.. The 510(k) number is K842130.

When did G.I. CLEANSING KIT receive FDA 510(k) clearance?

G.I. CLEANSING KIT received FDA 510(k) clearance on 1984-08-08, under 510(k) number K842130.

Who is the listed applicant for G.I. CLEANSING KIT?

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 G.I. CLEANSING KIT?

The FDA product code for G.I. CLEANSING KIT is FCE.

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 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.

K905026DUAL FLEX NON-LATEXK860445CLAMP-N-CUT

Related Devices (Code: FCE)

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.

K974042AMSURE CLEANSING ENEMA SETAmsino Intl., Inc.K931896PRO-FLO SYSTEMLafayette Pharmacal, Inc.K9223984 SURE TM ENEMA BAG SETBoston Pacific Medical, Inc.K913620ENEMA KITYork County Blind CenterK904534ENEMA BULBR.A.C., Inc.K901182ENEMA BAG SETOrion Life Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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