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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 K991395
Device Name QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM
Applicant
ADVANCED REPRODUCTIVE TECHNOLOGIES
3722 AVENUE SAUSALITO
IRVINE,  CA  92606
Applicant Contact GRER HOLLAND
Correspondent
ADVANCED REPRODUCTIVE TECHNOLOGIES
3722 AVENUE SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GRER HOLLAND
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/21/1999
Decision Date 02/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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