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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 K003448
Device Name DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
Applicant
Irvine Scientific Sales Co., Inc.
2511 Daimler St.
Santa Ana,  CA  92705
Applicant Contact WENDELL LEE
Correspondent
Irvine Scientific Sales Co., Inc.
2511 Daimler St.
Santa Ana,  CA  92705
Correspondent Contact WENDELL LEE
Regulation Number884.6180
Classification Product Code
MQL  
Date Received11/06/2000
Decision Date 12/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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