The following data is part of a premarket notification filed by Numed, Inc. with the FDA for D'vill Introducer.
Device ID | K171206 |
510k Number | K171206 |
Device Name: | D'Vill Introducer |
Classification | Introducer, Catheter |
Applicant | NuMED, Inc. 2880 Main Street Hopkinton, NY 12965 |
Contact | Nichelle Laflesh |
Correspondent | Nichelle Laflesh NuMED, Inc. 2880 Main Street Hopkinton, NY 12965 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-25 |
Decision Date | 2017-10-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04046955128297 | K171206 | 000 |
04046955128280 | K171206 | 000 |
04046955128273 | K171206 | 000 |
04046955128266 | K171206 | 000 |
04046955128259 | K171206 | 000 |
04046955127702 | K171206 | 000 |