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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 K931722
Device Name CARAPACE LABOR AND DELIVERY SETS
Applicant
Carapace, Inc.
2701 W Concord St.
Broken Arrow,  OK  74012
Applicant Contact JERRY MYERS
Correspondent
Carapace, Inc.
2701 W Concord St.
Broken Arrow,  OK  74012
Correspondent Contact JERRY MYERS
Regulation Number884.4530
Classification Product Code
MLS  
Date Received04/07/1993
Decision Date 03/23/1994
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
Predetermined Change
Control Plan Authorized		 No
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