The following data is part of a premarket notification filed by Westmark, Sterile Packing Systems, Inc. (sps) with the FDA for Urethral Catheterization Trays.
| Device ID | K896212 |
| 510k Number | K896212 |
| Device Name: | URETHRAL CATHETERIZATION TRAYS |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| 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 | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-26 |
| Decision Date | 1990-01-24 |