The following data is part of a premarket notification filed by Ryder Intl. Corp. with the FDA for Assist(tm) Aseptic Syringe Irrigation System.
| Device ID | K881981 |
| 510k Number | K881981 |
| Device Name: | ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM |
| Classification | Catheter, Urological |
| Applicant | RYDER INTL. CORP. 3240 N. INDIANAPOLIS RD. P.O. BOX 448 Columbus, IN 47202 |
| Contact | Anthony J Moravec |
| Correspondent | Anthony J Moravec RYDER INTL. CORP. 3240 N. INDIANAPOLIS RD. P.O. BOX 448 Columbus, IN 47202 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-12 |
| Decision Date | 1988-08-02 |