The following data is part of a premarket notification filed by Sterile Design, Inc. with the FDA for Sterile Design-custom Sterile Iv Kit.
| Device ID | K842351 |
| 510k Number | K842351 |
| Device Name: | STERILE DESIGN-CUSTOM STERILE IV KIT |
| Classification | Set, Administration, Intravascular |
| Applicant | STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar, FL 34677 -0137 |
| Contact | John C Hoffman |
| Correspondent | John C Hoffman STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar, FL 34677 -0137 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-15 |
| Decision Date | 1984-10-15 |