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FDA 510(k)

MAC LEE SITZ BATH

K-Number: K841711 · 1984-05-07

ApplicantMac Lee Medical Products
Decision Date1984-05-07
Product CodeKTC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MAC LEE SITZ BATH 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 1984-05-07 under 510(k) number K841711. The device is classified under product code KTC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAC LEE SITZ BATH?

MAC LEE SITZ BATH is a medical device that received FDA 510(k) clearance on 1984-05-07. The listed applicant is Mac Lee Medical Products. The 510(k) number is K841711.

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

MAC LEE SITZ BATH received FDA 510(k) clearance on 1984-05-07, under 510(k) number K841711.

Who is the listed applicant for MAC LEE SITZ BATH?

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 SITZ BATH?

The FDA product code for MAC LEE SITZ BATH is KTC.

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: KTC)

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.

K912179THE SPRITZ BATHThe Spritz Co.K890085SIT-N-BATHE SITZ BATHDrummond Industries, Inc.K862600SITZ BATHW. C. Green, D.D.S.K851309ABCO PLASTIC UTENSILSAbco Dealers, Inc.K831762SITZ BATH, SINGLE PATIENT USE #8100Lsl Industries, Inc.K800958PERSONAL SITZ BATH KITThe Healthcare Group Laboratories, 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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