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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Obstetric (And Accessories)
510(k) Number K884868
Device Name OBSTETRICAL SAFETY SYSTEM
Applicant
Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Applicant Contact DAVID W SCHLERF
Correspondent
Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact DAVID W SCHLERF
Regulation Number884.4900
Classification Product Code
KNC  
Date Received11/21/1988
Decision Date 03/01/1989
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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