510(k) K052900

QUILL NONABSORBABLE NYLON BARBED SUTURE by Quill Medical, Inc. — Product Code GAR

K052900 is an FDA 510(k) premarket notification submitted by Quill Medical, Inc. for the device "QUILL NONABSORBABLE NYLON BARBED SUTURE". The FDA issued a decision of Substantially Equivalent on November 28, 2005. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Quill Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2005
Date Received
October 14, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type