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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sampler, Amniotic Fluid (Amniocentesis Tray)
510(k) Number K960203
Device Name G.E. STERILE AMNIOCENTESIS TRAY
Applicant
GE Medical Systems
1247 Flordia Ave.
Palm Harbor,  FL  34683
Applicant Contact PATRICK J LAMB
Correspondent
GE Medical Systems
1247 Flordia Ave.
Palm Harbor,  FL  34683
Correspondent Contact PATRICK J LAMB
Regulation Number884.1550
Classification Product Code
HIO  
Subsequent Product Code
HGL  
Date Received01/16/1996
Decision Date 03/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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