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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, water, reproduction, assisted, and purification
510(k) Number K011598
Device Name WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
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 Number884.6170
Classification Product Code
MTW  
Date Received05/24/2001
Decision Date 06/13/2001
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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