The following data is part of a premarket notification filed by Megaplast, Inc. with the FDA for Syringe, Ent.
| Device ID | K810251 |
| 510k Number | K810251 |
| Device Name: | SYRINGE, ENT |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | MEGAPLAST, 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 | 1981-01-29 |
| Decision Date | 1981-03-11 |