The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Sims Silo Needle De-access Enclosure.
| Device ID | K935767 |
| 510k Number | K935767 |
| Device Name: | SIMS SILO NEEDLE DE-ACCESS ENCLOSURE |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa J Stone |
| Correspondent | Lisa J Stone SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-02 |
| Decision Date | 1995-11-15 |