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FDA 510(k)

SepaSperm Washing Solution, SepaSperm Solution

K-Number: K190199 · 2019-09-26

ApplicantKitazato Corporation
Decision Date2019-09-26
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SepaSperm Washing Solution, SepaSperm Solution is a medical device manufactured by Kitazato Corporation. It received FDA 510(k) clearance on 2019-09-26 under approval number K190199. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SepaSperm Washing Solution, SepaSperm Solution?

SepaSperm Washing Solution, SepaSperm Solution is a medical device that received FDA 510(k) clearance on 2019-09-26. It is manufactured by Kitazato Corporation. The 510(k) number is K190199.

When was SepaSperm Washing Solution, SepaSperm Solution approved by the FDA?

SepaSperm Washing Solution, SepaSperm Solution received FDA 510(k) clearance on 2019-09-26, under approval number K190199.

What company makes SepaSperm Washing Solution, SepaSperm Solution?

SepaSperm Washing Solution, SepaSperm Solution is manufactured by Kitazato Corporation.

What is the FDA product code for SepaSperm Washing Solution, SepaSperm Solution?

The FDA product code for SepaSperm Washing Solution, SepaSperm Solution is MQL.

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Related Devices (Code: MQL)

K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd. K153478Sydney IVF Gamete BufferWilliam A. Cook Australia Pty. , Ltd. K160863PBS(-), Phosphate Buffered SalineKitazato Biopharma Co., Ltd. K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitWilliam A. Cook Australia Pty. , Ltd. K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitWillian A. Cook Australia Pty, 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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