The following data is part of a premarket notification filed by Renovo, Inc. with the FDA for Reprocessed Covidien Trocar.
Device ID | K172093 |
510k Number | K172093 |
Device Name: | Reprocessed Covidien Trocar |
Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
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 | NLM |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-11 |
Decision Date | 2017-10-05 |
Summary: | summary |