The following data is part of a premarket notification filed by Medcare Disp Products, Inc. with the FDA for Syringe Irrigating.
| Device ID | K821530 |
| 510k Number | K821530 |
| Device Name: | SYRINGE IRRIGATING |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | MEDCARE DISP PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-21 |
| Decision Date | 1982-05-28 |