The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd-prizm Model 6100 Pump.
| Device ID | K960826 |
| 510k Number | K960826 |
| Device Name: | CADD-PRIZM MODEL 6100 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 | 1996-02-29 |
| Decision Date | 1996-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610586039102 | K960826 | 000 |