The following data is part of a premarket notification filed by York County Blind Center with the FDA for Enema Kit.
| Device ID | K913620 |
| 510k Number | K913620 |
| Device Name: | ENEMA KIT |
| Classification | Enema Kit |
| Applicant | YORK COUNTY BLIND CENTER 1380 SPAHN AVE. York, PA 17403 |
| Contact | Willliam Rhinesmith |
| Correspondent | Willliam Rhinesmith YORK COUNTY BLIND CENTER 1380 SPAHN AVE. York, PA 17403 |
| Product Code | FCE |
| CFR Regulation Number | 876.5210 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-13 |
| Decision Date | 1991-11-01 |