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FDA 510(k)

DRUG RECONSTITUTION FILTER DEVICE

K-Number: K941020 · 1994-08-10

ApplicantGelman Sciences, Inc.
Decision Date1994-08-10
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DRUG RECONSTITUTION FILTER DEVICE 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 1994-08-10 under 510(k) number K941020. 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 DRUG RECONSTITUTION FILTER DEVICE?

DRUG RECONSTITUTION FILTER DEVICE is a medical device that received FDA 510(k) clearance on 1994-08-10. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K941020.

When did DRUG RECONSTITUTION FILTER DEVICE receive FDA 510(k) clearance?

DRUG RECONSTITUTION FILTER DEVICE received FDA 510(k) clearance on 1994-08-10, under 510(k) number K941020.

Who is the listed applicant for DRUG RECONSTITUTION FILTER DEVICE?

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 DRUG RECONSTITUTION FILTER DEVICE?

The FDA product code for DRUG RECONSTITUTION FILTER DEVICE 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 FILTERSK941589SYRINGE FILTER DEVICESK942275VIAL 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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