510(k) K060414

KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE by Kmi Kolster Methods, Inc. — Product Code GAW

K060414 is an FDA 510(k) premarket notification submitted by Kmi Kolster Methods, Inc. for the device "KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE". The FDA issued a decision of Substantially Equivalent on October 23, 2006. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Kmi Kolster Methods, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2006
Date Received
February 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type