The following data is part of a premarket notification filed by Rama Corp. with the FDA for Dental Warm Water Irrigating System.
| Device ID | K781594 |
| 510k Number | K781594 |
| Device Name: | DENTAL WARM WATER IRRIGATING SYSTEM |
| Classification | Unit, Syringe, Air And/or Water |
| Applicant | RAMA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ECB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-15 |
| Decision Date | 1978-12-04 |