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 |