The following data is part of a premarket notification filed by Innovative Surgical Products Inc. with the FDA for Pleural Drainage Reservoir.
| Device ID | K820765 |
| 510k Number | K820765 |
| Device Name: | PLEURAL DRAINAGE RESERVOIR |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | INNOVATIVE SURGICAL PRODUCTS INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-22 |
| Decision Date | 1982-04-15 |