MEDI-CULT SPERM FREEZE MEDIUM

Media, Reproductive

MEDICULT A/S

The following data is part of a premarket notification filed by Medicult A/s with the FDA for Medi-cult Sperm Freeze Medium.

Pre-market Notification Details

Device IDK991333
510k NumberK991333
Device Name:MEDI-CULT SPERM FREEZE MEDIUM
ClassificationMedia, Reproductive
Applicant MEDICULT A/S 9915 CAM. CHIRIMOLLA San Diego,  CA  92131
ContactRonald G Leonardi
CorrespondentRonald G Leonardi
MEDICULT A/S 9915 CAM. CHIRIMOLLA San Diego,  CA  92131
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-19
Decision Date2000-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888937800678 K991333 000

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