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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 K991471
Device Name MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015)
Applicant
MEDICULT A/S
P.O. BOX 262069
SAN DIEGO,  CA  92196 -2069
Applicant Contact RONALD G LEONARDI
Correspondent
MEDICULT A/S
P.O. BOX 262069
SAN DIEGO,  CA  92196 -2069
Correspondent Contact RONALD G LEONARDI
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/14/1999
Decision Date 05/09/2000
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
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