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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 K900316
Device Name MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES
Applicant
IRVINE SCIENTIFIC
2511 DAIMLER ST.
SANTA ANA,  CA  92705
Applicant Contact PAUL WEATHERSBEE
Correspondent
IRVINE SCIENTIFIC
2511 DAIMLER ST.
SANTA ANA,  CA  92705
Correspondent Contact PAUL WEATHERSBEE
Regulation Number884.5250
Classification Product Code
HDR  
Date Received01/23/1990
Decision Date 04/16/1990
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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