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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 K894405
Device Name HTF WITH ALBUMIN (CATALOG NO. 9994)
Applicant
Irvine Scientific
2511 Daimler St.
Santa Ana,  CA  92705
Applicant Contact PAUL WEATHERSBEE,PHD
Correspondent
Irvine Scientific
2511 Daimler St.
Santa Ana,  CA  92705
Correspondent Contact PAUL WEATHERSBEE,PHD
Regulation Number884.5250
Classification Product Code
HDR  
Date Received07/17/1989
Decision Date 09/22/1989
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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