The following data is part of a premarket notification filed by Renovo, Inc. with the FDA for Reprocessed Shavers/burs.
Device ID | K172092 |
510k Number | K172092 |
Device Name: | Reprocessed Shavers/Burs |
Classification | Arthroscope |
Applicant | Renovo, Inc. 340 SW Columbia St. Bend, OR 97702 |
Contact | Mark K. Wells |
Correspondent | Robert V. Packard Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, VT 05738 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-11 |
Decision Date | 2017-10-04 |
Summary: | summary |