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FDA 510(k)

1500 ML DISPOSABLE ENEMA CONTAINER(1110)

K-Number: K800960 · 1980-05-14

ApplicantThe Healthcare Group Laboratories, Inc.
Decision Date1980-05-14
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

1500 ML DISPOSABLE ENEMA CONTAINER(1110) is the device name listed in this FDA 510(k) record. The listed applicant is The Healthcare Group Laboratories, Inc.. It received FDA 510(k) clearance on 1980-05-14 under 510(k) number K800960. 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 1500 ML DISPOSABLE ENEMA CONTAINER(1110)?

1500 ML DISPOSABLE ENEMA CONTAINER(1110) is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is The Healthcare Group Laboratories, Inc.. The 510(k) number is K800960.

When did 1500 ML DISPOSABLE ENEMA CONTAINER(1110) receive FDA 510(k) clearance?

1500 ML DISPOSABLE ENEMA CONTAINER(1110) received FDA 510(k) clearance on 1980-05-14, under 510(k) number K800960.

Who is the listed applicant for 1500 ML DISPOSABLE ENEMA CONTAINER(1110)?

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

What is the FDA product code for 1500 ML DISPOSABLE ENEMA CONTAINER(1110)?

The FDA product code for 1500 ML DISPOSABLE ENEMA CONTAINER(1110) is FCE.

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Other records listing The Healthcare Group Laboratories, 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.

K850035EMPTY SOLUTION TRANSFER CONTAINERK842170EMPTY SOLUTION TRANSFER CONTAINERK842091DISPOS. ACU-CUT SOFT TISSUE BIOPSYK840742RIGHT ATRIAL CATHETERK830299SOLUTION TRANSFER CONTAINERK822307ADHESIVE SPRAY #4050-4060

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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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