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Cord Blood Processing System And Storage Container

Cryo-Cell International, Inc.

The following data is part of a premarket notification filed by Cryo-cell International, Inc. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK190356
510k NumberBK190356
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationCord Blood Processing System And Storage Container
Applicant Cryo-Cell International, Inc. 700 Brooker Creek Blvd Oldsmar,  FL  34677 US
Product CodeOAO  
CFR Regulation Number864.9900 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-03
Decision Date2020-06-17

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