510(k) K073651

NEOTRACT ANCHOR SYSTEM by Neotract, Inc. — Product Code GAT

K073651 is an FDA 510(k) premarket notification submitted by Neotract, Inc. for the device "NEOTRACT ANCHOR SYSTEM". The FDA issued a decision of Substantially Equivalent on February 1, 2008. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Neotract, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2008
Date Received
December 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type