The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for 3-day Release Of Ethylene Oxide Device.
| Device ID | K832352 |
| 510k Number | K832352 |
| Device Name: | 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | PARKE-DAVIS CO. 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 | 1983-07-15 |
| Decision Date | 1984-01-13 |