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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 K983586
Device Name HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI
Applicant
Irvine Scientific Sales Co., Inc.
2511 Daimler St.
Santa Ana,  CA  92705
Applicant Contact ROBERTA L JOHNSON
Correspondent
Irvine Scientific Sales Co., Inc.
2511 Daimler St.
Santa Ana,  CA  92705
Correspondent Contact ROBERTA L JOHNSON
Regulation Number884.6180
Classification Product Code
MQL  
Date Received10/13/1998
Decision Date 02/18/1999
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
Predetermined Change
Control Plan Authorized		 No
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