The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Pleural Drainage System #pds-4300.
| Device ID | K812224 |
| 510k Number | K812224 |
| Device Name: | PLEURAL DRAINAGE SYSTEM #PDS-4300 |
| Classification | Bottle, Collection, Vacuum |
| Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-10 |
| Decision Date | 1981-09-09 |