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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Assisted Reproduction
510(k) Number K002595
Device Name CBS STRAW
Applicant
Cryo Bio System
3722 Ave. Saualito
Irvine,  CA  92606
Applicant Contact GABRIELE LINGENOLELE
Correspondent
Cryo Bio System
3722 Ave. Saualito
Irvine,  CA  92606
Correspondent Contact GABRIELE LINGENOLELE
Regulation Number884.6120
Classification Product Code
MQG  
Date Received08/21/2000
Decision Date 11/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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