The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Pharmacia Deltec Extension Set With Anti-siphon Valve.
Device ID | K942046 |
510k Number | K942046 |
Device Name: | PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE |
Classification | Set, Administration, Intravascular |
Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | David H Short |
Correspondent | David H Short 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 | 1994-04-28 |
Decision Date | 1994-10-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
35019517184208 | K942046 | 000 |