The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd Administration Set.
Device ID | K991599 |
510k Number | K991599 |
Device Name: | CADD ADMINISTRATION SET |
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 | 1999-05-10 |
Decision Date | 1999-06-15 |
Summary: | summary |