The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd-legacy Pca Ambulatory Infusion System, Model 6300.
| Device ID | K982839 |
| 510k Number | K982839 |
| Device Name: | CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 |
| Classification | Pump, Infusion, Pca |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Edward W Numainville |
| Correspondent | Edward W Numainville SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-12 |
| Decision Date | 1998-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610586035098 | K982839 | 000 |
| 10610586019326 | K982839 | 000 |
| 30610586042717 | K982839 | 000 |
| 10610586043161 | K982839 | 000 |
| 10610586021725 | K982839 | 000 |
| 10610586019449 | K982839 | 000 |
| 10610586019357 | K982839 | 000 |