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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K961860
Device Name A4907 LENS CLEANING SHEATH
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact BARRY E SANDS
Correspondent
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact BARRY E SANDS
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
GCJ  
Date Received05/14/1996
Decision Date 08/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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