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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 K861188
Device Name SPERM CAPACITATION MEDIUM
Applicant
Irvine Scientific
Charles H. Newman
25283 Cabot Rd., Suite 207
Laguna Hills,  CA  92653
Applicant Contact NEWMAN ASSOC.
Correspondent
Irvine Scientific
Charles H. Newman
25283 Cabot Rd., Suite 207
Laguna Hills,  CA  92653
Correspondent Contact NEWMAN ASSOC.
Regulation Number884.5250
Classification Product Code
HDR  
Date Received03/31/1986
Decision Date 01/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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