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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 K022748
Device Name REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
Applicant
MEDICAL DEVICE SERVICES
144 WEST BRIGHAM RD.
BLDG E
ST. GEORGE,  UT  84790
Applicant Contact MARK ALDANA
Correspondent
MEDICAL DEVICE SERVICES
144 WEST BRIGHAM RD.
BLDG E
ST. GEORGE,  UT  84790
Correspondent Contact MARK ALDANA
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
HDM  
Date Received08/19/2002
Decision Date 10/09/2002
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
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