The following data is part of a premarket notification filed by Chase Mfg. Co. with the FDA for Enema Set.
| Device ID | K771792 |
| 510k Number | K771792 |
| Device Name: | ENEMA SET |
| Classification | Enema Kit |
| Applicant | CHASE MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FCE |
| CFR Regulation Number | 876.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-09-22 |
| Decision Date | 1977-10-20 |