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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ligator, hemorrhoidal
510(k) Number K001236
Device Name RIZA BAND STRETCHER (RBS)-60000
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 Number876.4400
Classification Product Code
FHN  
Date Received04/18/2000
Decision Date 07/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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