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FDA 510(k)

GENT-L-KARE CLEANSING ENEMA SET

K-Number: K881218 · 1988-07-28

ApplicantGeneva Laboratories, Inc.
Decision Date1988-07-28
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GENT-L-KARE CLEANSING ENEMA SET is the device name listed in this FDA 510(k) record. The listed applicant is Geneva Laboratories, Inc.. It received FDA 510(k) clearance on 1988-07-28 under 510(k) number K881218. 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 GENT-L-KARE CLEANSING ENEMA SET?

GENT-L-KARE CLEANSING ENEMA SET is a medical device that received FDA 510(k) clearance on 1988-07-28. The listed applicant is Geneva Laboratories, Inc.. The 510(k) number is K881218.

When did GENT-L-KARE CLEANSING ENEMA SET receive FDA 510(k) clearance?

GENT-L-KARE CLEANSING ENEMA SET received FDA 510(k) clearance on 1988-07-28, under 510(k) number K881218.

Who is the listed applicant for GENT-L-KARE CLEANSING ENEMA SET?

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

What is the FDA product code for GENT-L-KARE CLEANSING ENEMA SET?

The FDA product code for GENT-L-KARE CLEANSING ENEMA SET is FCE.

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Other records listing Geneva 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.

K881217GENT-L-KARE STERILE URINARY LEG BAGK881213GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTERK881216GENT-L-KARE VAGINAL IRRIGATION SETK861308ACCUPAC CUSTOM PACK KERLIX SQUARESK861219ACCUPAC CUSTOM SKIN SCRUB KITK853265ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543

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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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