The following data is part of a premarket notification filed by Surgical Devices, A Division Of Tyco Healthcare with the FDA for V-loc 180 Absorbable Wound Closure Device.
| Device ID | K093408 |
| 510k Number | K093408 |
| Device Name: | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Contact | Nishith Desai |
| Correspondent | Nishith Desai SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-02 |
| Decision Date | 2009-11-12 |
| Summary: | summary |