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FDA 510(k)

MAC LEE ENEMAD

K-Number: K791863 · 1979-10-02

ApplicantMac Lee Medical Products
Decision Date1979-10-02
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAC LEE ENEMAD 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 1979-10-02 under 510(k) number K791863. 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 MAC LEE ENEMAD?

MAC LEE ENEMAD is a medical device that received FDA 510(k) clearance on 1979-10-02. The listed applicant is Mac Lee Medical Products. The 510(k) number is K791863.

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

MAC LEE ENEMAD received FDA 510(k) clearance on 1979-10-02, under 510(k) number K791863.

Who is the listed applicant for MAC LEE ENEMAD?

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 ENEMAD?

The FDA product code for MAC LEE ENEMAD is FCE.

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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 SETK864781MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CCK864777MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CCK864778MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC

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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.K901182ENEMA BAG 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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