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FDA 510(k)

SCALP VEIN SET

K-Number: K870995 · 1987-07-31

ApplicantMac Lee Medical Products
Decision Date1987-07-31
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SCALP VEIN SET 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 1987-07-31 under 510(k) number K870995. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCALP VEIN SET?

SCALP VEIN SET is a medical device that received FDA 510(k) clearance on 1987-07-31. The listed applicant is Mac Lee Medical Products. The 510(k) number is K870995.

When did SCALP VEIN SET receive FDA 510(k) clearance?

SCALP VEIN SET received FDA 510(k) clearance on 1987-07-31, under 510(k) number K870995.

Who is the listed applicant for SCALP VEIN SET?

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 SCALP VEIN SET?

The FDA product code for SCALP VEIN SET is FPA.

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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 CUFFK864778MACLEE/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

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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