510(k) K190027
- Device
- SteriStay
- Applicant
- Toul Meditech AB
- 510(k) number
- K190027
- Product code
- ORC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-05-10
- Date received
- 2019-01-07
- Regulation
- 878.5070
- Classification name
- Air Filter Portable Apparatus
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tomas Hansson
- Address
- Tunbytorpsgatan 31 Vasteras SE 72137 72137
FDA Registration Numbers#
- 3012992602
- 3009756327
Source Documents#
Other 510(k) Records For Product Code ORC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K173349 | Operio | Toul Meditech AB | 2017-12-20 |
| K163455 | SurgiCube | Surgicube International B.V. | 2017-09-28 |
| K153498 | Operio | Toul Meditech AB | 2016-07-20 |
| K123006 | AIR BARRIER SYSTEM (ABS) | Nimbic Systems, Inc. | 2013-12-20 |
| K092801 | ABS BLOWER, ABS NOZZLE, MODEL 1001 | Nimbic Systems, LLC | 2011-05-20 |
Legacy Summary#
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FDA Review#
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