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FDA 510(k)

ENEMA KIT

K-Number: K913620 · 1991-11-01

ApplicantYork County Blind Center
Decision Date1991-11-01
Product CodeFCE
Advisory CommitteeGU
DecisionUnknown

Device Summary

ENEMA KIT is the device name listed in this FDA 510(k) record. The listed applicant is York County Blind Center. It received FDA 510(k) clearance on 1991-11-01 under 510(k) number K913620. The device is classified under product code FCE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ENEMA KIT?

ENEMA KIT is a medical device that received FDA 510(k) clearance on 1991-11-01. The listed applicant is York County Blind Center. The 510(k) number is K913620.

When did ENEMA KIT receive FDA 510(k) clearance?

ENEMA KIT received FDA 510(k) clearance on 1991-11-01, under 510(k) number K913620.

Who is the listed applicant for ENEMA KIT?

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

What is the FDA product code for ENEMA KIT?

The FDA product code for ENEMA KIT is FCE.

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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.K904534ENEMA BULBR.A.C., Inc.K901182ENEMA BAG SETOrion Life Systems, Inc.K901179ENEMA BUCKET 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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