The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Deseret Epidural Catheter W/toughy-borst Adapter.
| Device ID | K850505 |
| 510k Number | K850505 |
| Device Name: | DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER |
| 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 | 1985-02-08 |
| Decision Date | 1985-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382904032505 | K850505 | 000 |
| 50382904005073 | K850505 | 000 |