KENDRO HERACELL 240 INCUBATOR


Device Classification Name

accessory, assisted reproduction

510(k) Number K023465
Device Name KENDRO HERACELL 240 INCUBATOR
Original Applicant
KENDRO LABORATORY PRODUCTS, L.P.
p.o. box 2156
huntington, 
CT 
06484

Original Contact joseph m azary
Regulation Number 884.6120
Classification Product Code
MQG  
Date Received 10/15/2002
Decision Date 03/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No