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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 K001600
Device Name CODA INCUBATOR CELLMATE
Applicant
<GENX> INTL., INC.
170 FORT PATH RD.
UNIT 14
MADISON,  CT  06443
Applicant Contact MICHAEL D CECCHI
Correspondent
INTL., INC.
170 FORT PATH RD.
UNIT 14
MADISON,  CT  06443
Correspondent Contact MICHAEL D CECCHI
Regulation Number884.6120
Classification Product Code
MQG  
Date Received05/24/2000
Decision Date 11/22/2000
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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