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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amniotome
510(k) Number K926425
Device Name AMNIPERF(TM)
Applicant
Raymart Development Co.
C/O D.L. Nelson &M Associates
2902 Marlin Circle
Atlanta,  GA  30341
Applicant Contact DENNIS L NELSON
Correspondent
Raymart Development Co.
C/O D.L. Nelson &M Associates
2902 Marlin Circle
Atlanta,  GA  30341
Correspondent Contact DENNIS L NELSON
Regulation Number884.4530
Classification Product Code
HGE  
Date Received12/23/1992
Decision Date 03/07/1994
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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