The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd-pca, -micro, -prizm Ambulatory Infusion Pump.
| Device ID | K955180 |
| 510k Number | K955180 |
| Device Name: | CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | David H Short |
| Correspondent | David H Short SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-05-23 |
| Summary: | summary |