The following data is part of a premarket notification filed by Entellus Medical, Inc. with the FDA for Pathassist Light Seeker.
Device ID | K133563 |
510k Number | K133563 |
Device Name: | PATHASSIST LIGHT SEEKER |
Classification | Instrument, Ent Manual Surgical |
Applicant | Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 |
Contact | Garrett P Ahlborg |
Correspondent | Garrett P Ahlborg Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 |
Product Code | LRC |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-20 |
Decision Date | 2013-12-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857326005154 | K133563 | 000 |