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FDA 510(k)

BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET

K-Number: K955727 · 1996-02-08

ApplicantI-Flow Corp.
Decision Date1996-02-08
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is I-Flow Corp.. It received FDA 510(k) clearance on 1996-02-08 under 510(k) number K955727. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET?

BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 1996-02-08. The listed applicant is I-Flow Corp.. The 510(k) number is K955727.

When did BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET receive FDA 510(k) clearance?

BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET received FDA 510(k) clearance on 1996-02-08, under 510(k) number K955727.

Who is the listed applicant for BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET?

The FDA 510(k) record lists I-Flow Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET?

The FDA product code for BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET is MEB.

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Other records listing I-Flow Corp. 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.

K063530ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMPK063234ON-Q INTRODUCERSK051401ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETERK052117I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)K043456MODIFICATION TO SOAKER CATHETERK040337I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)

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Related Devices (Code: MEB)

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.

K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.K240624InfuLifeFirst Medical Source, LLCK242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.K181360ON-Q* Pump with BolusHalyard HealthK151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.K131247MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEMMfs - Medical Flow Systems, 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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