The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Sims Deltec Anti-siphon Valve.
Device ID | K954870 |
510k Number | K954870 |
Device Name: | SIMS DELTEC ANTI-SIPHON VALVE |
Classification | Set, Administration, Intravascular |
Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | David Short |
Correspondent | David Short 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 | 1995-10-24 |
Decision Date | 1995-12-15 |