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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K900878
Device Name OTT INSUFFLATION FILTER TUBING
Applicant
Gynescope Corp.
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Applicant Contact SCOTT C MARLOW
Correspondent
Gynescope Corp.
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Correspondent Contact SCOTT C MARLOW
Regulation Number884.1730
Classification Product Code
HIF  
Date Received02/26/1990
Decision Date 05/07/1990
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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