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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 K950076
Device Name LAPAROSCOPE
Applicant
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Applicant Contact BARRY E SANDS
Correspondent
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Correspondent Contact BARRY E SANDS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/09/1995
Decision Date 03/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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