The following data is part of a premarket notification filed by Precision Dermatology Incorporated with the FDA for Precision Skin Emulsion.
| Device ID | K111168 |
| 510k Number | K111168 |
| Device Name: | PRECISION SKIN EMULSION |
| Classification | Dressing, Wound, Drug |
| Applicant | PRECISION DERMATOLOGY INCORPORATED 900 HIGHLAND CORPORATE DRIVE Cumberland, RI 02864 |
| Contact | Ronald M Gurge, Ph.d |
| Correspondent | Ronald M Gurge, Ph.d PRECISION DERMATOLOGY INCORPORATED 900 HIGHLAND CORPORATE DRIVE Cumberland, RI 02864 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-25 |
| Decision Date | 2011-12-13 |
| Summary: | summary |