The following data is part of a premarket notification filed by Elliquence, Llc with the FDA for Endiscope, Endiscope Cervical.
Device ID | K180766 |
510k Number | K180766 |
Device Name: | Endiscope, Endiscope Cervical |
Classification | Arthroscope |
Applicant | Elliquence, LLC 2455 Grand Avenue Baldwin, NY 11510 |
Contact | Paul D. Buhrke |
Correspondent | Paul D. Buhrke Elliquence, LLC 2455 Grand Avenue Baldwin, NY 11510 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-23 |
Decision Date | 2018-06-11 |
Summary: | summary |