The following data is part of a premarket notification filed by Kmi Kolster Methods, Inc. with the FDA for Featherlift Extended Aptos Thread.
Device ID | K043591 |
510k Number | K043591 |
Device Name: | FEATHERLIFT EXTENDED APTOS THREAD |
Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
Applicant | KMI KOLSTER METHODS, INC. 3185 PALISADES DR. Corona, CA 92882 |
Contact | Keith Davis |
Correspondent | Keith Davis KMI KOLSTER METHODS, INC. 3185 PALISADES DR. Corona, CA 92882 |
Product Code | GAW |
CFR Regulation Number | 878.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-12-28 |
Decision Date | 2005-03-04 |