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FDA 510(k)

DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF

K-Number: K872006 · 1987-11-17

ApplicantMac Lee Medical Products
Decision Date1987-11-17
Product CodeFGD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF 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 1987-11-17 under 510(k) number K872006. The device is classified under product code FGD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF?

DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF is a medical device that received FDA 510(k) clearance on 1987-11-17. The listed applicant is Mac Lee Medical Products. The 510(k) number is K872006.

When did DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF receive FDA 510(k) clearance?

DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF received FDA 510(k) clearance on 1987-11-17, under 510(k) number K872006.

Who is the listed applicant for DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF?

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 DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF?

The FDA product code for DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF is FGD.

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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 SETK870995SCALP VEIN SETK864778MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CCK864779MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CCK864777MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CCK864781MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC

View all 14 devices →

Related Devices (Code: FGD)

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.

K223890NAJA Gastrointestinal CatheterChess Medical, Inc.K905026DUAL FLEX NON-LATEXMmi, Inc.K905574SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFFE-Z-Em, Inc.K904299SLIM LINE RETENT TIP W/SILICONE INFLATION CUFFE-Z-Em, Inc.K884379MAGLINTE ENTEROCLYSIS CATHETERLafayette Pharmacal, 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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