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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 K060983
Device Name BIOPSY MEDIUM, MODEL REF 1062
Applicant
MEDICULT A/S
9915 CAM. CHIRIMOLLA
SAN DIEGO,  CA  92131
Applicant Contact RONALD G LEONARDI
Correspondent
MEDICULT A/S
9915 CAM. CHIRIMOLLA
SAN DIEGO,  CA  92131
Correspondent Contact RONALD G LEONARDI
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/10/2006
Decision Date 07/28/2006
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
Recalls CDRH Recalls
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