The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Mini Ghost, Model: 507.
Device ID | K082524 |
510k Number | K082524 |
Device Name: | MINI GHOST, MODEL: 507 |
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 | 2008-09-02 |
Decision Date | 2008-09-26 |
Summary: | summary |