The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Infusion Sets #'s 124 & 142 Personal.
| Device ID | K831445 |
| 510k Number | K831445 |
| Device Name: | INFUSION SETS #'S 124 & 142 PERSONAL |
| Classification | Set, Administration, Intravascular |
| Applicant | PACESETTER SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-05 |
| Decision Date | 1983-09-12 |