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FDA 510(k) Application Details - K001236
Device Classification Name
Ligator, Hemorrhoidal
More FDA Info for this Device
510(K) Number
K001236
Device Name
Ligator, Hemorrhoidal
Applicant
R-MED, INC.
3465 NAVARRE AVE., BOX 167636
OREGON, OH 43616-7636 US
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Contact
EROL D RIZA
Other 510(k) Applications for this Contact
Regulation Number
876.4400
More FDA Info for this Regulation Number
Classification Product Code
FHN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/18/2000
Decision Date
07/17/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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