The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Deseret Epidural Catheter.
Device ID | K850439 |
510k Number | K850439 |
Device Name: | DESERET EPIDURAL CATHETER |
Classification | Catheter, Conduction, Anesthetic |
Applicant | PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
Contact | Cleary |
Correspondent | Cleary PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
Product Code | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-05 |
Decision Date | 1985-03-05 |