The following data is part of a premarket notification filed by Plasco, Inc. with the FDA for Macbick Disposable Barium Enema Syst 4800 & 4700.
| Device ID | K880337 |
| 510k Number | K880337 |
| Device Name: | MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 |
| 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 | 1988-01-26 |
| Decision Date | 1988-04-14 |