The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Pharmacia Deltec Bag Spike Set.
Device ID | K873876 |
510k Number | K873876 |
Device Name: | PHARMACIA DELTEC BAG SPIKE SET |
Classification | Set, Administration, Intravascular |
Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | Edward Numainville |
Correspondent | Edward Numainville PHARMACIA 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 | 1987-09-22 |
Decision Date | 1987-10-23 |