The following data is part of a premarket notification filed by Porex Medical with the FDA for Tls Bulb Drainage System.
| Device ID | K833586 |
| 510k Number | K833586 |
| Device Name: | TLS BULB DRAINAGE SYSTEM |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | POREX MEDICAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-12 |
| Decision Date | 1984-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613252088432 | K833586 | 000 |
| 37613252088470 | K833586 | 000 |
| 37613252088463 | K833586 | 000 |
| 37613252088449 | K833586 | 000 |
| 37613252083574 | K833586 | 000 |
| 37613252083567 | K833586 | 000 |
| 37613252083550 | K833586 | 000 |
| 37613252083543 | K833586 | 000 |