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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Labor And Delivery Kit
510(k) Number K961993
Device Name BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)
Applicant
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Applicant Contact GEORGE AUSTRIA
Correspondent
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Correspondent Contact GEORGE AUSTRIA
Regulation Number884.4530
Classification Product Code
MLS  
Date Received05/21/1996
Decision Date 07/03/1996
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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