The following data is part of a premarket notification filed by Rsp, Inc. with the FDA for Epidural Catheter.
Device ID | K823702 |
510k Number | K823702 |
Device Name: | EPIDURAL CATHETER |
Classification | Catheter, Conduction, Anesthetic |
Applicant | RSP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-09 |
Decision Date | 1983-01-07 |