Micromanipulators And Microinjectors, Assisted Reproduction

Device Code: 4029

Product Code(s): MQJ

Device Classification Information

Device Type ID4029
Device NameMicromanipulators And Microinjectors, Assisted Reproduction
Regulation DescriptionAssisted Reproduction Micromanipulators And Microinjectors.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission Type510(K) Exempt
CFR Regulation Number884.6150 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMQJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID4029
DeviceMicromanipulators And Microinjectors, Assisted Reproduction
Product CodeMQJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAssisted Reproduction Micromanipulators And Microinjectors.
CFR Regulation Number884.6150 [🔎]
Premarket Reviews
ManufacturerDecision
EPPENDORF AG
 
SUBSTANTIALLY EQUIVALENT
1
Recalls
Manufacturer Recall Class Date Posted
1
RESEARCH INSTRUMENTS LTD - SITE B
II Apr-28-2016
TPLC Last Update: 2019-04-02 20:41:53

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