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FDA 510(k)

PBC SYRINGE

K-Number: K813647 · 1982-01-25

ApplicantPhiladelphia Biologics Center
Decision Date1982-01-25
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PBC SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Philadelphia Biologics Center. It received FDA 510(k) clearance on 1982-01-25 under 510(k) number K813647. 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 PBC SYRINGE?

PBC SYRINGE is a medical device that received FDA 510(k) clearance on 1982-01-25. The listed applicant is Philadelphia Biologics Center. The 510(k) number is K813647.

When did PBC SYRINGE receive FDA 510(k) clearance?

PBC SYRINGE received FDA 510(k) clearance on 1982-01-25, under 510(k) number K813647.

Who is the listed applicant for PBC SYRINGE?

The FDA 510(k) record lists Philadelphia Biologics Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PBC SYRINGE?

The FDA product code for PBC SYRINGE is FMF.

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Other records listing Philadelphia Biologics Center 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.

K841717INTRAVENOUS INJECTION SETK834256PBC SYRINGE IRRIGATINGK834255PBC SCALP VEIN SETK834253PBC IV SET NON-VENTEDK834254PBC IV SET VENTEDK834252PBC EXTENSION SET

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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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