The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Extension Set With Microbore Tubing, Extension Set With Microbore Tubing And 0.2 U Filter, Extension Set With Microbore.
| Device ID | K974013 |
| 510k Number | K974013 |
| Device Name: | EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE |
| 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 | 1997-10-22 |
| Decision Date | 1997-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517184222 | K974013 | 000 |