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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Cervical
510(k) Number K872102
Device Name SPERM WASHING MEDIUM #9932
Applicant
IRVINE SCIENTIFIC
2511 DAIMLER ST.
SANTA ANA,  CA  92705
Applicant Contact S WEATHERSBEE
Correspondent
IRVINE SCIENTIFIC
2511 DAIMLER ST.
SANTA ANA,  CA  92705
Correspondent Contact S WEATHERSBEE
Regulation Number884.5250
Classification Product Code
HDR  
Date Received06/01/1987
Decision Date 07/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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