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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 K002805
Device Name KENDRO HERACELL CO2 INCUBATOR
Applicant
Kendro Laboratory Products, L.P.
55 Northern Blvd.; Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Kendro Laboratory Products, L.P.
55 Northern Blvd.; Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number884.6120
Classification Product Code
MQG  
Date Received09/08/2000
Decision Date 11/09/2000
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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