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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 K944200
Device Name HI-Q HAND INSTRUMENTS, OB/GYN USE
Applicant
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042
Applicant Contact BARRY E SANDS
Correspondent
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042
Correspondent Contact BARRY E SANDS
Regulation Number884.1720
Classification Product Code
HET  
Date Received08/29/1994
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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