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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 K080172
Device Name BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
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 Received01/24/2008
Decision Date 12/18/2008
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 Yes
Predetermined Change
Control Plan Authorized		 No
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