The following data is part of a premarket notification filed by Kendall Research Center with the FDA for Syringe, Irrigation, Pre-filled.
| Device ID | K772134 |
| 510k Number | K772134 |
| Device Name: | SYRINGE, IRRIGATION, PRE-FILLED |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | KENDALL RESEARCH CENTER 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-14 |
| Decision Date | 1977-11-28 |