The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd-prizm High Volume Administration Set With 1.2 U Filter And Add-on Anti-siphon Valve, Cadd Administration Set With 1.
| Device ID | K991301 |
| 510k Number | K991301 |
| Device Name: | CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 |
| 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 | 1999-04-16 |
| Decision Date | 1999-06-09 |
| Summary: | summary |