The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Z-med Ptv Catherers.
Device ID | K003643 |
510k Number | K003643 |
Device Name: | NUMED Z-MED PTV CATHERERS |
Classification | Catheter, Percutaneous |
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 | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-27 |
Decision Date | 2000-12-27 |