The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd Administration Set, Cadd 250ml Flexible Medication Reservoir, Modified Securit Shell, Security Shell Adapter.
| Device ID | K990083 |
| 510k Number | K990083 |
| Device Name: | CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-11 |
| Decision Date | 1999-02-12 |
| Summary: | summary |