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 |