The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Sterile Drainage System.
| Device ID | K833571 |
| 510k Number | K833571 |
| Device Name: | STERILE DRAINAGE SYSTEM |
| Classification | Collector, Ostomy |
| Applicant | COLOPLAST A/S 6206 BENJAMIN RD. Tampa, FL 33614 |
| Contact | Antonio M Ojeda |
| Correspondent | Antonio M Ojeda COLOPLAST A/S 6206 BENJAMIN RD. Tampa, FL 33614 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-12 |
| Decision Date | 1984-01-30 |