The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Tyshak Nucleus.
Device ID | K121859 |
510k Number | K121859 |
Device Name: | TYSHAK NUCLEUS |
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 | 2012-06-26 |
Decision Date | 2012-08-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04046964511950 | K121859 | 000 |
04046964511752 | K121859 | 000 |
04046964511745 | K121859 | 000 |
04046964511738 | K121859 | 000 |
04046964511721 | K121859 | 000 |
04046964511714 | K121859 | 000 |
04046964511707 | K121859 | 000 |
04046964511691 | K121859 | 000 |
04046964511684 | K121859 | 000 |
04046964511677 | K121859 | 000 |
04046964511660 | K121859 | 000 |
04046964511653 | K121859 | 000 |
04046964511646 | K121859 | 000 |
04046964511639 | K121859 | 000 |
04046964511622 | K121859 | 000 |
04046964511615 | K121859 | 000 |
04046964511608 | K121859 | 000 |
04046964511769 | K121859 | 000 |
04046964511776 | K121859 | 000 |
04046964511783 | K121859 | 000 |
04046964511943 | K121859 | 000 |
04046964511936 | K121859 | 000 |
04046964511929 | K121859 | 000 |
04046964511912 | K121859 | 000 |
04046964511905 | K121859 | 000 |
04046964511899 | K121859 | 000 |
04046964511882 | K121859 | 000 |
04046964511875 | K121859 | 000 |
04046964511868 | K121859 | 000 |
04046964511851 | K121859 | 000 |
04046964511844 | K121859 | 000 |
04046964511837 | K121859 | 000 |
04046964511820 | K121859 | 000 |
04046964511813 | K121859 | 000 |
04046964511806 | K121859 | 000 |
04046964511790 | K121859 | 000 |
04046964511493 | K121859 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TYSHAK NUCLEUS 86282081 4733127 Live/Registered |
NuMED, Inc. 2014-05-15 |