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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 K041952
Device Name ZIVF-AIRE
Applicant
Zander Medical Supplies, Inc.
755 8th Ct., Suite 4
P.O. Box 650790
Vero Beach,  FL  32965
Applicant Contact FRED ZANDER
Correspondent
Zander Medical Supplies, Inc.
755 8th Ct., Suite 4
P.O. Box 650790
Vero Beach,  FL  32965
Correspondent Contact FRED ZANDER
Regulation Number884.6120
Classification Product Code
MQG  
Date Received07/20/2004
Decision Date 09/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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