FDA 510(k) Application Details - K001236

Device Classification Name Ligator, Hemorrhoidal

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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
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Regulation Number 876.4400

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Classification Product Code FHN
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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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