Custom Sterile Procedure Kits
FDA 510(k) K842356 · Sterile Design, Inc.
510(k) numberK842356
Submission
- Device name
- Custom Sterile Procedure Kits
- Applicant
- Sterile Design, Inc.
Oldsmar, FL, US - Received
- June 15, 1984
- Decision date
- March 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Sterile Design, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934688 | Sterile DesignLRO · Traditional | 03/16/1994SEKD |
| K841960 | Cardio Metrics Invasive Pressure MonitDRS · Traditional | 11/08/1985SE |
| K841959 | Cardio Metric Custom Perfusion TubingDWE · Traditional | 10/19/1984SE |
| K842351 | Sterile Design-Custom Sterile IV KitFPA · Traditional | 10/15/1984SE |
| K841958 | Cardio Metrics Cardiotomy ReservoirJOD · Traditional | 10/15/1984SE |
| K834239 | Sdi C-Flex Sterile Light Handle · Traditional | 04/25/1984SE |
| K834237 | Graduated Guide Wire Bowl 8DQX · Traditional | 02/04/1984SE |
| K813437 | Pan SetFRG · Traditional | 12/31/1981SE |
| K791738 | Custom Dressing Change TraysFMC · Traditional | 10/02/1979SE |
Questions and answers
When was Custom Sterile Procedure Kits cleared by the FDA?
Custom Sterile Procedure Kits (K842356) received a 510(k) decision of Substantially Equivalent on March 21, 1985, 279 days after the submission was received.