DermaTherapy Bed Linens
FDA 510(k) clearance K152884 · decided 2016-06-20
Clearance details
- K-number
- K152884
- Device name
- DermaTherapy Bed Linens
- Applicant
- Precision Fabrics Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-30
- Decision date
- 2016-06-20
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- FMW
- Device class
- 1
- Regulation number
- 880.6190
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Greensboro, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Precision Fabrics Group
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.