The following data is part of a premarket notification filed by American Bentley with the FDA for Pleural Drainage Sys #pds-100-4.
| Device ID | K831849 |
| 510k Number | K831849 |
| Device Name: | PLEURAL DRAINAGE SYS #PDS-100-4 |
| Classification | Apparatus, Autotransfusion |
| Applicant | AMERICAN BENTLEY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-08 |
| Decision Date | 1983-12-29 |