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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 K892220
Device Name LAMINARIA TENT
Applicant
BERKELEY MEDEVICES
907 CAMELIA ST.
BERKELEY,  CA  94710
Applicant Contact JULIE CASELLI
Correspondent
BERKELEY MEDEVICES
907 CAMELIA ST.
BERKELEY,  CA  94710
Correspondent Contact JULIE CASELLI
Regulation Number884.4260
Classification Product Code
HDY  
Date Received04/03/1989
Decision Date 06/14/1989
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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