The following data is part of a premarket notification filed by Salt Creek Medical Technologies with the FDA for Extension Sets.
| Device ID | K864692 |
| 510k Number | K864692 |
| Device Name: | EXTENSION SETS |
| Classification | Tubing, Fluid Delivery |
| Applicant | SALT CREEK MEDICAL TECHNOLOGIES 5509 MIDDLETOWN RD. Canfield, OH 44406 |
| Contact | Howard Meade |
| Correspondent | Howard Meade SALT CREEK MEDICAL TECHNOLOGIES 5509 MIDDLETOWN RD. Canfield, OH 44406 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-02 |
| Decision Date | 1986-12-18 |