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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 K991229
Device Name K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L
Applicant
Henning Knudsen Engineering A/S
Klintehoj Vaenge 1
Birkerod,  DK DK-3460
Applicant Contact JACOB MOLLENBACH
Correspondent
Henning Knudsen Engineering A/S
Klintehoj Vaenge 1
Birkerod,  DK DK-3460
Correspondent Contact JACOB MOLLENBACH
Regulation Number884.6120
Classification Product Code
MQG  
Date Received04/12/1999
Decision Date 06/29/1999
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
Predetermined Change
Control Plan Authorized		 No
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