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FDA 510(k)

SYRINGE FILTER DEVICES

K-Number: K941589 · 1994-09-06

ApplicantGelman Sciences, Inc.
Decision Date1994-09-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYRINGE FILTER DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Sciences, Inc.. It received FDA 510(k) clearance on 1994-09-06 under 510(k) number K941589. 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 SYRINGE FILTER DEVICES?

SYRINGE FILTER DEVICES is a medical device that received FDA 510(k) clearance on 1994-09-06. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K941589.

When did SYRINGE FILTER DEVICES receive FDA 510(k) clearance?

SYRINGE FILTER DEVICES received FDA 510(k) clearance on 1994-09-06, under 510(k) number K941589.

Who is the listed applicant for SYRINGE FILTER DEVICES?

The FDA 510(k) record lists Gelman Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYRINGE FILTER DEVICES?

The FDA product code for SYRINGE FILTER DEVICES is FMF.

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Other records listing Gelman Sciences, Inc. 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.

K946190DRUG DISPENSING SPIKEK943127PHARMASSURE LARGE VOLUME TRANSFER FILTERSK941020DRUG RECONSTITUTION FILTER DEVICEK942275VIAL VENT FILTERK941032UNKNOWNK910821TRANSDUCER PROTECTOR

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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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