The following data is part of a premarket notification filed by Plasco, Inc. with the FDA for The Lahr Balloon.
| Device ID | K870019 |
| 510k Number | K870019 |
| Device Name: | THE LAHR BALLOON |
| Classification | Enema Kit |
| Applicant | PLASCO, INC. 3849 SWANSON ST. Gurnee, IL 60031 -1225 |
| Contact | Michael S Fales |
| Correspondent | Michael S Fales PLASCO, INC. 3849 SWANSON ST. Gurnee, IL 60031 -1225 |
| Product Code | FCE |
| CFR Regulation Number | 876.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-02 |
| Decision Date | 1987-04-01 |