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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K960144
Device Name G.E. STERILE CT BIOPSY 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 Number870.4500
Classification Product Code
DWS  
Date Received01/16/1996
Decision Date 04/15/1996
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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