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FDA 510(k)

3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM

K-Number: K994148 · 2000-02-01

ApplicantImplant Innovations, Inc.
Decision Date2000-02-01
Product CodeJQC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implant Innovations, Inc.. It received FDA 510(k) clearance on 2000-02-01 under 510(k) number K994148. The device is classified under product code JQC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM?

3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-02-01. The listed applicant is Implant Innovations, Inc.. The 510(k) number is K994148.

When did 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM receive FDA 510(k) clearance?

3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM received FDA 510(k) clearance on 2000-02-01, under 510(k) number K994148.

Who is the listed applicant for 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM?

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

What is the FDA product code for 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM?

The FDA product code for 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM is JQC.

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Other records listing Implant Innovations, 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.

K062636OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTSK0633413I OSSEOTITE CERTAIN DENTAL IMPLANTSK063286OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITEK063403CONICAL ANGLED ABUTMENTK061629CERTAIN PREVAIL DENTAL IMPLANTK062432NANOTITE DENTAL IMPLANTS

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Related Devices (Code: JQC)

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.

K183205PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL SystemEmcyte CorporationK103340SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEMHarvest Technologies, Corp.K081345AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)Thermogenesis Corp.K071934MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KITBiomet Manufacturing CorpK070666GENESISCS COMPONENT CONCENTRATING SYSTEMPerfusion Partners & Assoc., Inc.K052925SMARTPREP2 CENTRIFUGE SYSTEMHarvest Technologies, Corp.

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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