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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 K991341
Device Name ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION
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 Received04/19/1999
Decision Date 07/08/1999
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
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