The following data is part of a premarket notification filed by Kmi Kolster Methods, Inc. with the FDA for Kolster Methods, Inc., Featherlift Silhouette Suture.
Device ID | K060414 |
510k Number | K060414 |
Device Name: | KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE |
Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
Applicant | KMI KOLSTER METHODS, INC. 3185 PALISADES DR. Corona, CA 92882 |
Contact | Jeffrey A Kolster |
Correspondent | Jeffrey A Kolster 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 | 2006-02-16 |
Decision Date | 2006-10-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
5060033040249 | K060414 | 000 |
05060033040218 | K060414 | 000 |
5060033040201 | K060414 | 000 |
5060033040188 | K060414 | 000 |