The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Tyshak, Model 102 And Z-med, Model 302.
| Device ID | K991977 |
| 510k Number | K991977 |
| Device Name: | TYSHAK, MODEL 102 AND Z-MED, MODEL 302 |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Contact | Nichelle Laflesh |
| Correspondent | Nichelle Laflesh NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-11 |
| Decision Date | 2000-09-27 |
| Summary: | summary |