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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 K991335
Device Name MEDI-CULT FREEZING & THAWING PACKS
Applicant
MEDICULT A/S
9915 CAM. CHIRIMOLLA
SAN DIEGO,  CA  92131
Applicant Contact RTONALD G LEONARDI
Correspondent
MEDICULT A/S
9915 CAM. CHIRIMOLLA
SAN DIEGO,  CA  92131
Correspondent Contact RTONALD G LEONARDI
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/19/1999
Decision Date 02/28/2000
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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