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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 K932216
Device Name C-SECTION, LABOR & DELIVERY TRAYS (PACKS)
Applicant
Associated Medical Products Co.
3250 Gorham Ave.
St. Louis Park,  MN  55426
Applicant Contact SCOTT WEISS
Correspondent
Associated Medical Products Co.
3250 Gorham Ave.
St. Louis Park,  MN  55426
Correspondent Contact SCOTT WEISS
Regulation Number884.4530
Classification Product Code
MLS  
Date Received05/07/1993
Decision Date 04/19/1994
Decision Substantially Equivalent - Kit (SESK)
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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