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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 DESOTO AVE.
CHATSWORTH,  CA  91311 -5084
Applicant Contact GEORGE AUSTRIA
Correspondent
DEVON INDUSTRIES, INC.
9530 DESOTO AVE.
CHATSWORTH,  CA  91311 -5084
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
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