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FDA 510(k)

STERILE AMBULATORY RESERVOIR 60ML/100ML

K-Number: K962159 · 1997-07-18

ApplicantFaulding Medical Device Co.
Decision Date1997-07-18
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE AMBULATORY RESERVOIR 60ML/100ML is the device name listed in this FDA 510(k) record. The listed applicant is Faulding Medical Device Co.. It received FDA 510(k) clearance on 1997-07-18 under 510(k) number K962159. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE AMBULATORY RESERVOIR 60ML/100ML?

STERILE AMBULATORY RESERVOIR 60ML/100ML is a medical device that received FDA 510(k) clearance on 1997-07-18. The listed applicant is Faulding Medical Device Co.. The 510(k) number is K962159.

When did STERILE AMBULATORY RESERVOIR 60ML/100ML receive FDA 510(k) clearance?

STERILE AMBULATORY RESERVOIR 60ML/100ML received FDA 510(k) clearance on 1997-07-18, under 510(k) number K962159.

Who is the listed applicant for STERILE AMBULATORY RESERVOIR 60ML/100ML?

The FDA 510(k) record lists Faulding Medical Device Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE AMBULATORY RESERVOIR 60ML/100ML?

The FDA product code for STERILE AMBULATORY RESERVOIR 60ML/100ML is MRZ.

Related Clinical Trials

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.

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Other records listing Faulding Medical Device Co. 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.

K970909SAFE-CONNECT I.V. SETK970789SAFE-CONNECT VIAL DISPENSING SPIKEK971266SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518K970524SAFE-CONNECT I.V. EXTENSION SETK955775SAFECONNECT VALVE (CATALOG NO. XXXX)

Related Devices (Code: MRZ)

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.

K230718UTC 3mL Medication CartridgeGilero, LLCK220695Elite Biomedical Solutions Dose Request CordElite Biomedical SolutionsK201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.K193654BlueStar RxWelldoc, Inc.K191910SpaceStation MRIB. Braun Melsugen AGK190013WellDoc BlueStarWelldoc, Inc.

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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