The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Infusion Sets Models 9120,9121,9125, 9122 & 9123.
| Device ID | K852060 |
| 510k Number | K852060 |
| Device Name: | INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 |
| Classification | Pump, Infusion |
| Applicant | CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Contact | Ann H Morrissey |
| Correspondent | Ann H Morrissey CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-09 |
| Decision Date | 1985-06-07 |