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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K121701
Model ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) SOFTWARE VERSION 4
Device Name SYSTEMS INTEGRATION
Original Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 corporate parkway
p.o. box 610
center valley,  PA  18034 0610
Original Contact kathy anderson
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
ODA  
Date Received06/08/2012
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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