FDA 510(k) Application Details - K042659

Device Classification Name Forceps, Biopsy, Non-Electric, Reprocessed

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510(K) Number K042659
Device Name Forceps, Biopsy, Non-Electric, Reprocessed
Applicant MEDISISS
2747 SW 6TH STREET
REDMOND, OR 97756 US
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Contact BRANDI JAMES
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Regulation Number 876.1075

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Classification Product Code NON
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Date Received 09/28/2004
Decision Date 02/14/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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