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FDA 510(k)

MAC LEE VAGINAL IRRIGATOR

K-Number: K841710 · 1984-06-19

ApplicantMac Lee Medical Products
Decision Date1984-06-19
Product CodeHED
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MAC LEE VAGINAL IRRIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mac Lee Medical Products. It received FDA 510(k) clearance on 1984-06-19 under 510(k) number K841710. 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 MAC LEE VAGINAL IRRIGATOR?

MAC LEE VAGINAL IRRIGATOR is a medical device that received FDA 510(k) clearance on 1984-06-19. The listed applicant is Mac Lee Medical Products. The 510(k) number is K841710.

When did MAC LEE VAGINAL IRRIGATOR receive FDA 510(k) clearance?

MAC LEE VAGINAL IRRIGATOR received FDA 510(k) clearance on 1984-06-19, under 510(k) number K841710.

Who is the listed applicant for MAC LEE VAGINAL IRRIGATOR?

The FDA 510(k) record lists Mac Lee Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAC LEE VAGINAL IRRIGATOR?

The FDA product code for MAC LEE VAGINAL IRRIGATOR is HED.

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Other records listing Mac Lee Medical Products 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.

K872953DISPOSABLE I.V. ADMINISTRATION SETK872006DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFFK870995SCALP VEIN SETK864777MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CCK864778MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CCK864779MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC

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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.K881216GENT-L-KARE VAGINAL IRRIGATION SETGeneva Laboratories, Inc.K854595P.A. MEDICAL VAGINAL IRRIGATION SET #1130Pa Medical Corp.

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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