510(k) K043591

FEATHERLIFT EXTENDED APTOS THREAD by Kmi Kolster Methods, Inc. — Product Code GAW

K043591 is an FDA 510(k) premarket notification submitted by Kmi Kolster Methods, Inc. for the device "FEATHERLIFT EXTENDED APTOS THREAD". The FDA issued a decision of Substantially Equivalent on March 4, 2005. 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
March 4, 2005
Date Received
December 28, 2004
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