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FDA 510(k)

MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC

K-Number: K864779 · 1986-12-29

ApplicantMac Lee Medical Products
Decision Date1986-12-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC 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 1986-12-29 under 510(k) number K864779. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC?

MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC is a medical device that received FDA 510(k) clearance on 1986-12-29. The listed applicant is Mac Lee Medical Products. The 510(k) number is K864779.

When did MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC receive FDA 510(k) clearance?

MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC received FDA 510(k) clearance on 1986-12-29, under 510(k) number K864779.

Who is the listed applicant for MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC?

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 MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC?

The FDA product code for MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC is FMF.

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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/CCK864781MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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