The following data is part of a premarket notification filed by Westmark, Sterile Packing Systems, Inc. (sps) with the FDA for Thoracic Catheters.
| Device ID | K883474 |
| 510k Number | K883474 |
| Device Name: | THORACIC CATHETERS |
| Classification | Catheter, Irrigation |
| Applicant | WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids, MI 49507 |
| Contact | Tim Sagers |
| Correspondent | Tim Sagers WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids, MI 49507 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-16 |
| Decision Date | 1988-09-13 |