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FDA 510(k)

GENT-L-KARE VAGINAL IRRIGATION SET

K-Number: K881216 · 1988-06-07

ApplicantGeneva Laboratories, Inc.
Decision Date1988-06-07
Product CodeHED
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GENT-L-KARE VAGINAL IRRIGATION 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 1988-06-07 under 510(k) number K881216. The device is classified under product code HED. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENT-L-KARE VAGINAL IRRIGATION SET?

GENT-L-KARE VAGINAL IRRIGATION SET is a medical device that received FDA 510(k) clearance on 1988-06-07. The listed applicant is Geneva Laboratories, Inc.. The 510(k) number is K881216.

When did GENT-L-KARE VAGINAL IRRIGATION SET receive FDA 510(k) clearance?

GENT-L-KARE VAGINAL IRRIGATION SET received FDA 510(k) clearance on 1988-06-07, under 510(k) number K881216.

Who is the listed applicant for GENT-L-KARE VAGINAL IRRIGATION 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 VAGINAL IRRIGATION SET?

The FDA product code for GENT-L-KARE VAGINAL IRRIGATION SET is HED.

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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 CENTERK881218GENT-L-KARE CLEANSING ENEMA SETK861308ACCUPAC CUSTOM PACK KERLIX SQUARESK861219ACCUPAC CUSTOM SKIN SCRUB KITK853265ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543

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Related Devices (Code: HED)

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.

K080200WATER WORKS DOUCHING DEVICEAbbott Research Group, Inc.K030056WORRY-REMOVER IRRIGATORCorisen Group, Ltd.K000736LA JOIEGoomi Ehwa, Inc.K902830PERI-BOTTLEOrion Life Systems, Inc.K854595P.A. MEDICAL VAGINAL IRRIGATION SET #1130Pa Medical Corp.K841710MAC LEE VAGINAL IRRIGATORMac Lee Medical Products

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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