The following data is part of a premarket notification filed by Regulatory Technology Services, Llc with the FDA for Vti Suction Irrigation System.
| Device ID | K141323 |
| 510k Number | K141323 |
| Device Name: | VTI SUCTION IRRIGATION SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Contact | Mark Job |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-05-20 |
| Decision Date | 2014-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817122020430 | K141323 | 000 |
| 00817122020423 | K141323 | 000 |
| 00817122020416 | K141323 | 000 |
| 00817122020065 | K141323 | 000 |
| 10817122020475 | K141323 | 000 |
| 10817122020031 | K141323 | 000 |
| 00817122020522 | K141323 | 000 |
| 00817122020515 | K141323 | 000 |