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 |