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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 K881295
Device Name LAMINARIA CUREX
Applicant
Harold W. Berger Co.
P.O. Box 767
Murrieta,  CA  92362
Applicant Contact HAROLD W BERGER
Correspondent
Harold W. Berger Co.
P.O. Box 767
Murrieta,  CA  92362
Correspondent Contact HAROLD W BERGER
Regulation Number884.4260
Classification Product Code
HDY  
Date Received03/28/1988
Decision Date 08/10/1988
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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