The following data is part of a premarket notification filed by Westmark, Sterile Packing Systems, Inc. (sps) with the FDA for Y-type Tur/continuous Bladder Irrigation Set.
| Device ID | K896213 |
| 510k Number | K896213 |
| Device Name: | Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET |
| Classification | Catheter, Urological |
| Applicant | WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids, MI 49507 |
| Contact | Sury Shoney |
| Correspondent | Sury Shoney WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids, MI 49507 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-26 |
| Decision Date | 1990-01-18 |