The following data is part of a premarket notification filed by Endius, Inc. with the FDA for Endius Atavi System.
Device ID | K022199 |
510k Number | K022199 |
Device Name: | ENDIUS ATAVI SYSTEM |
Classification | Arthroscope |
Applicant | ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
Contact | Christine Kuntz Nassif |
Correspondent | Christine Kuntz Nassif ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-05 |
Decision Date | 2002-10-02 |
Summary: | summary |