The following data is part of a premarket notification filed by Mcgrath Pharmaceuticals, Inc. with the FDA for Carapaste Oral Wound Dressing.
| Device ID | K082856 |
| 510k Number | K082856 |
| Device Name: | CARAPASTE ORAL WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | MCGRATH PHARMACEUTICALS, INC. 683 CENTER STREET UNIT C Grayslake, IL 60030 |
| Contact | Patrick D Mcgrath |
| Correspondent | Patrick D Mcgrath MCGRATH PHARMACEUTICALS, INC. 683 CENTER STREET UNIT C Grayslake, IL 60030 |
| 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 | 2008-09-29 |
| Decision Date | 2008-10-15 |
| Summary: | summary |