The following data is part of a premarket notification filed by Covidien Llc with the FDA for V-loc(tm) Nonabsorbable Wound Closure Device.
| Device ID | K103052 |
| 510k Number | K103052 |
| Device Name: | V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Covidien LLC 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Jennifer Brennan |
| Correspondent | Jennifer Brennan Covidien LLC 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-14 |
| Decision Date | 2010-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521128415 | K103052 | 000 |
| 20884521762555 | K103052 | 000 |
| 20884521762548 | K103052 | 000 |
| 20884521762531 | K103052 | 000 |
| 20884521762524 | K103052 | 000 |
| 20884521214719 | K103052 | 000 |
| 20884521171074 | K103052 | 000 |
| 20884521135298 | K103052 | 000 |
| 20884521134932 | K103052 | 000 |
| 20884521134925 | K103052 | 000 |
| 20884521134918 | K103052 | 000 |
| 20884521762562 | K103052 | 000 |
| 20884521135007 | K103052 | 000 |
| 10884521127920 | K103052 | 000 |
| 10884521127913 | K103052 | 000 |
| 10884521127906 | K103052 | 000 |
| 10884521127883 | K103052 | 000 |
| 10884521127876 | K103052 | 000 |
| 10884521127869 | K103052 | 000 |
| 10884521127845 | K103052 | 000 |
| 10884521127821 | K103052 | 000 |
| 10884521127814 | K103052 | 000 |
| 20884521780238 | K103052 | 000 |
| 20884521134901 | K103052 | 000 |