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FDA 510(k) Application Details - K031173
Device Classification Name
Guide, Needle, Surgical
More FDA Info for this Device
510(K) Number
K031173
Device Name
Guide, Needle, Surgical
Applicant
NEEDLETECH PRODUCTS, INC.
81 WEST ST.
ATTLEBORO, MA 02703 US
Other 510(k) Applications for this Company
Contact
RICK TRIPP
Other 510(k) Applications for this Contact
Regulation Number
878.4800
More FDA Info for this Regulation Number
Classification Product Code
GDF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2003
Decision Date
07/23/2003
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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