Modification to Augustine Medical Wound Care System, Model 68XXX
FDA 510(k) K020077 · Augustine Medical, Inc.
510(k) numberK020077
Submission
- Device name
- Modification to Augustine Medical Wound Care System, Model 68XXX
- Applicant
- Augustine Medical, Inc.
Eden Prairie, MN, US - Received
- January 9, 2002
- Decision date
- January 31, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSA – Dressing, Wound And Burn, Occlusive, Heated
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4020
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code MSA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963293 | Augustine Medical Wound Care System Model 68XXXMSA · Traditional | Augustine Medical, Inc. | 03/28/1997SN |
More from Augustine Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021473 | Bair Hugger Temperature Management SystemDWJ · Traditional | 07/09/2002SE |
| K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750…DWJ · Traditional | 09/06/2000SE |
| K973741 | Bair Hugger Blood/Fluid WarmerBSB · Traditional | 04/30/1998SE |
| K964673 | Bair Hugger Model 630 Cardiac BlanketDWJ · Traditional | 06/26/1997SE |
| K963293 | Augustine Medical Wound Care System Model 68XXXMSA · Traditional | 03/28/1997SN |
| K963672 | Model 90022 Rolling StandJOW · Traditional | 01/06/1997SE |
| K960167 | System, Thermal Regulating 74-DWJDWJ · Traditional | 06/17/1996SE |
| K954446 | Augustine Intubation GuideCCW · Traditional | 12/29/1995SE |
| K952864 | Bair Hugger Model 655 BlanketDWJ · Traditional | 09/12/1995SE |
| K950416 | Bair Hugger Model 600 Unit, BlanketsDWJ · Traditional | 08/29/1995SE |
Questions and answers
When was Modification to Augustine Medical Wound Care System, Model 68XXX cleared by the FDA?
Modification to Augustine Medical Wound Care System, Model 68XXX (K020077) received a 510(k) decision of Substantially Equivalent on January 31, 2002, 22 days after the submission was received.
What is the product code of K020077?
The FDA product code is MSA – Dressing, Wound And Burn, Occlusive, Heated, a Class I (low risk) device regulated under 21 CFR 878.4020.