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FDA 510(k) Application Details - K070836
Device Classification Name
Device, Percutaneous, Biopsy
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510(K) Number
K070836
Device Name
Device, Percutaneous, Biopsy
Applicant
CLEVEX INC.
9996 CARROUSEL CT
LOVELAND, OH 45140 US
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Contact
LENA SATTLER
Other 510(k) Applications for this Contact
Regulation Number
878.4800
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Classification Product Code
MJG
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More FDA Info for this Product Code
Date Received
03/27/2007
Decision Date
04/20/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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