The following data is part of a premarket notification filed by Tni Manufacturing, Inc. with the FDA for Long Sheath Or Ls, 70 Cm, Long Sheath Or Ls, 80 Cm, Long Sheath Or Ls, 90 Cm.
| Device ID | K152876 |
| 510k Number | K152876 |
| Device Name: | LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM |
| Classification | Catheter, Percutaneous |
| Applicant | TNI Manufacturing, Inc. 4635 NW 103rd Avenue Sunrise, FL 33351 |
| Contact | Daniel Sablyak |
| Correspondent | Marianne Grunwaldt INNEUROCO 4635 NW 103RD AVENU Sunrise, FL 33351 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-01-08 |
| Summary: | summary |