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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 K953360
Device Name R-MED ABDOMINAL WALL ELEVATOR
Applicant
R-MED, INC.
3465 NAVARRE AVE., BOX 167636
OREGON,  OH  43616 -7636
Applicant Contact EROL D RIZA
Correspondent
R-MED, INC.
3465 NAVARRE AVE., BOX 167636
OREGON,  OH  43616 -7636
Correspondent Contact EROL D RIZA
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/17/1995
Decision Date 01/11/1996
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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