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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K000619
Device Name SCANDINAVIAN IVF SCIENCES AB, G2.2
Applicant
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
1900 K STREET, N.W.
WASHINGTON,  DC  20006 -1108
Applicant Contact GARY L YINGLING
Correspondent
VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
1900 K STREET, N.W.
WASHINGTON,  DC  20006 -1108
Correspondent Contact GARY L YINGLING
Regulation Number884.6180
Classification Product Code
MQL  
Date Received02/17/2000
Decision Date 06/27/2000
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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