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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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