The following data is part of a premarket notification filed by Science Development Corp. with the FDA for Sdc Silicone Sump Drain.
| Device ID | K843617 |
| 510k Number | K843617 |
| Device Name: | SDC SILICONE SUMP DRAIN |
| Classification | Catheter, Irrigation |
| Applicant | SCIENCE DEVELOPMENT CORP. 6 PEARL COURT Allendale , NJ 07401 - |
| Contact | George E King |
| Correspondent | George E King SCIENCE DEVELOPMENT CORP. 6 PEARL COURT Allendale , NJ 07401 - |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-14 |
| Decision Date | 1984-10-24 |