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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
Device Name SYSTEMS INTEGRATION
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
P.O. BOX 610
CENTER VALLEY,  PA  18034 -0610
Applicant Contact KATHY ANDERSON
Correspondent
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
P.O. BOX 610
CENTER VALLEY,  PA  18034 -0610
Correspondent 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 (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
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