The following data is part of a premarket notification filed by Precision Fabrics Group, Inc. with the FDA for Dermatherapy, Model 22216.
| Device ID | K061242 |
| 510k Number | K061242 |
| Device Name: | DERMATHERAPY, MODEL 22216 |
| Classification | Cover, Mattress (medical Purposes) |
| Applicant | PRECISION FABRICS GROUP, INC. 18 BRIDIE LANE Norfolk, MA 02056 |
| Contact | Pamela J Weagraff |
| Correspondent | Pamela J Weagraff PRECISION FABRICS GROUP, INC. 18 BRIDIE LANE Norfolk, MA 02056 |
| Product Code | FMW |
| CFR Regulation Number | 880.6190 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-05-03 |
| Decision Date | 2007-01-25 |
| Summary: | summary |