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FDA 510(k)

SAFE MATE I.V. EXTENSION SETS

K-Number: K962801 · 1996-08-28

ApplicantBiological & Environmental Control Laboratories
Decision Date1996-08-28
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE MATE I.V. EXTENSION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Biological & Environmental Control Laboratories. It received FDA 510(k) clearance on 1996-08-28 under 510(k) number K962801. 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 SAFE MATE I.V. EXTENSION SETS?

SAFE MATE I.V. EXTENSION SETS is a medical device that received FDA 510(k) clearance on 1996-08-28. The listed applicant is Biological & Environmental Control Laboratories. The 510(k) number is K962801.

When did SAFE MATE I.V. EXTENSION SETS receive FDA 510(k) clearance?

SAFE MATE I.V. EXTENSION SETS received FDA 510(k) clearance on 1996-08-28, under 510(k) number K962801.

Who is the listed applicant for SAFE MATE I.V. EXTENSION SETS?

The FDA 510(k) record lists Biological & Environmental Control Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE MATE I.V. EXTENSION SETS?

The FDA product code for SAFE MATE I.V. EXTENSION SETS is FPA.

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Other records listing Biological & Environmental Control Laboratories 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.

K971500ACCESS SYSTEMS NEEDLELESS VIAL ADAPTERK962802SAFE MATE I.V. FLUID DELIVERY SETSK961328BEC SHROUDED PLASTIC CANNULAK961327BEC NEEDLELESS INJECTION SITEK863635UPDATED STERILE ENDOTRACHEAL BRUSHESK863633SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES

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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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