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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 K941507
FOIA Releasable 510(k) K941507
Device Name THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM
Applicant
SANESE MEDICAL CORP.
885 NORTHWEST BLVD.
COLUMBUS,  OH  43212
Applicant Contact CHRISTOPHER N SANESE
Correspondent
SANESE MEDICAL CORP.
885 NORTHWEST BLVD.
COLUMBUS,  OH  43212
Correspondent Contact CHRISTOPHER N SANESE
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/29/1994
Decision Date 03/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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