The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Sof Set, Models 113 And 114.
| Device ID | K860857 |
| 510k Number | K860857 |
| Device Name: | SOF SET, MODELS 113 AND 114 |
| Classification | Pump, Infusion |
| Applicant | PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Contact | Joseph J Schwoebel |
| Correspondent | Joseph J Schwoebel PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-07 |
| Decision Date | 1986-05-27 |