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FDA 510(k)

ENEMA BAG SET

K-Number: K901182 · 1990-06-28

ApplicantOrion Life Systems, Inc.
Decision Date1990-06-28
Product CodeFCE
Advisory CommitteeGU
DecisionUnknown

Device Summary

ENEMA BAG SET is the device name listed in this FDA 510(k) record. The listed applicant is Orion Life Systems, Inc.. It received FDA 510(k) clearance on 1990-06-28 under 510(k) number K901182. 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 BAG SET?

ENEMA BAG SET is a medical device that received FDA 510(k) clearance on 1990-06-28. The listed applicant is Orion Life Systems, Inc.. The 510(k) number is K901182.

When did ENEMA BAG SET receive FDA 510(k) clearance?

ENEMA BAG SET received FDA 510(k) clearance on 1990-06-28, under 510(k) number K901182.

Who is the listed applicant for ENEMA BAG SET?

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

What is the FDA product code for ENEMA BAG SET?

The FDA product code for ENEMA BAG SET is FCE.

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Other records listing Orion Life Systems, Inc. as applicant

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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.K913620ENEMA KITYork County Blind CenterK904534ENEMA BULBR.A.C., Inc.K901179ENEMA BUCKET SETOrion Life Systems, Inc.

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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