The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Enema Kit 'straight' Design.
| Device ID | K900848 |
| 510k Number | K900848 |
| Device Name: | ENEMA KIT 'STRAIGHT' DESIGN |
| Classification | Enema Kit |
| Applicant | CUSTOM MEDICAL PRODUCTS, LTD. 4101 SPRING MILL WAY Maineville, OH 45039 |
| Contact | George C Schuler |
| Correspondent | George C Schuler CUSTOM MEDICAL PRODUCTS, LTD. 4101 SPRING MILL WAY Maineville, OH 45039 |
| Product Code | FCE |
| CFR Regulation Number | 876.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-22 |
| Decision Date | 1990-04-13 |