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FDA 510(k)

ENHANCE SPERM FREEZE

K-Number: K030117 · 2003-03-20

ApplicantConception Technology, Inc.
Decision Date2003-03-20
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENHANCE SPERM FREEZE is the device name listed in this FDA 510(k) record. The listed applicant is Conception Technology, Inc.. It received FDA 510(k) clearance on 2003-03-20 under 510(k) number K030117. 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 ENHANCE SPERM FREEZE?

ENHANCE SPERM FREEZE is a medical device that received FDA 510(k) clearance on 2003-03-20. The listed applicant is Conception Technology, Inc.. The 510(k) number is K030117.

When did ENHANCE SPERM FREEZE receive FDA 510(k) clearance?

ENHANCE SPERM FREEZE received FDA 510(k) clearance on 2003-03-20, under 510(k) number K030117.

Who is the listed applicant for ENHANCE SPERM FREEZE?

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

What is the FDA product code for ENHANCE SPERM FREEZE?

The FDA product code for ENHANCE SPERM FREEZE is MQL.

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Other records listing Conception Technology, 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.

K030116ENHANCE-S PLUS HK991322ENHANCE-S PLUSK991104MICROTOOLSK973860OVULON MONITOR

Related Devices (Code: MQL)

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.

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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