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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Cervical, Hygroscopic-Laminaria
510(k) Number K955072
Device Name LAMINARIA
Applicant
CTI CORP., LTD.
607 ELMIRA RD.
VACAVILLE,  CA  95687
Applicant Contact OSCAR PELAEZ TAN
Correspondent
CTI CORP., LTD.
607 ELMIRA RD.
VACAVILLE,  CA  95687
Correspondent Contact OSCAR PELAEZ TAN
Regulation Number884.4260
Classification Product Code
HDY  
Date Received11/06/1995
Decision Date 05/22/1996
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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