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FDA 510(k) Application Details - K152795
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyamide
More FDA Info for this Device
510(K) Number
K152795
Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Applicant
RIVERPOINT MEDICAL
825 NE 25TH AVENUE
PORTLAND, OR 97232 US
Other 510(k) Applications for this Company
Contact
Edwin Anderson
Other 510(k) Applications for this Contact
Regulation Number
878.5020
More FDA Info for this Regulation Number
Classification Product Code
GAR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/28/2015
Decision Date
10/28/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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