The following data is part of a premarket notification filed by Precision Fabrics Group, Inc. with the FDA for Dermatherapy Bed Linens.
| Device ID | K152884 |
| 510k Number | K152884 |
| Device Name: | DermaTherapy Bed Linens |
| Classification | Cover, Mattress (medical Purposes) |
| Applicant | PRECISION FABRICS GROUP, INC. 301 N. ELM ST. SUITE 600 Greensboro, NC 27401 |
| Contact | Terry Montgomery |
| Correspondent | Jonathan Kahan HOGAN LOVELLS US LLP 555 13th Street NW Washington, DC 20004 |
| Product Code | FMW |
| CFR Regulation Number | 880.6190 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810019801419 | K152884 | 000 |
| 00810019801402 | K152884 | 000 |
| 00810019801396 | K152884 | 000 |
| 00810019801389 | K152884 | 000 |
| 00810019801372 | K152884 | 000 |
| 00810019801365 | K152884 | 000 |
| 00810019801358 | K152884 | 000 |