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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 -0790
Applicant Contact FRED ZANDER
Correspondent
ZANDER MEDICAL SUPPLIES, INC.
755 8TH CT., SUITE #4
P.O. BOX 650790
VERO BEACH,  FL  32965 -0790
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
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