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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 K003184
Device Name RS BIOTECH GALAXY 'R' CO2 INCUBATOR
Applicant
ZANDER MEDICAL SUPPLIES, INC.
755 8TH CT., SUITE #4
P.O.650790
VERO BEACH,  FL  32965 -0790
Applicant Contact FRIEDEL MW ZANDER
Correspondent
ZANDER MEDICAL SUPPLIES, INC.
755 8TH CT., SUITE #4
P.O.650790
VERO BEACH,  FL  32965 -0790
Correspondent Contact FRIEDEL MW ZANDER
Regulation Number884.6120
Classification Product Code
MQG  
Date Received10/11/2000
Decision Date 11/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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