The following data is part of a premarket notification filed by Fssb Chirurgische Nadeln Gmbh with the FDA for Fssb Nylon Surgical Sutures.
Device ID | K060471 |
510k Number | K060471 |
Device Name: | FSSB NYLON SURGICAL SUTURES |
Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
Applicant | FSSB CHIRURGISCHE NADELN GMBH 719 A STREET, NE. Washington, DC 20002 |
Contact | Cherita James |
Correspondent | Cherita James FSSB CHIRURGISCHE NADELN GMBH 719 A STREET, NE. Washington, DC 20002 |
Product Code | GAR |
CFR Regulation Number | 878.5020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-23 |
Decision Date | 2006-07-26 |
Summary: | summary |