The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Sof Set, Models 111 And 112.
Device ID | K861436 |
510k Number | K861436 |
Device Name: | SOF SET, MODELS 111 AND 112 |
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 | 1986-04-17 |
Decision Date | 1986-06-09 |