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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name labware, assisted reproduction
510(k) Number K122982
Device Name CRYOLOCK
Applicant
BIOTECH, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact ROBYN SCOPIS
Correspondent
BIOTECH, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact ROBYN SCOPIS
Regulation Number884.6160
Classification Product Code
MQK  
Date Received09/26/2012
Decision Date 01/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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