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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 K936120
Device Name LABOR AND DELIVERY TRAY
Applicant
CUSH MEDICAL PRODUCTS
P.O. BOX 247
881 MOUNTAIN VIEW DRIVE
PINEY FLATS,  TN  37686
Applicant Contact STEVE B JOHNSTON
Correspondent
CUSH MEDICAL PRODUCTS
P.O. BOX 247
881 MOUNTAIN VIEW DRIVE
PINEY FLATS,  TN  37686
Correspondent Contact STEVE B JOHNSTON
Regulation Number884.4530
Classification Product Code
MLS  
Date Received12/23/1993
Decision Date 03/30/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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