The following data is part of a premarket notification filed by Southwest Technologies, Inc. with the FDA for Otc Elasto-gel Manuka Honey Wound Dressing.
| Device ID | K102478 |
| 510k Number | K102478 |
| Device Name: | OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | SOUTHWEST TECHNOLOGIES, INC. 1746 LEVEE RD. Kansas City, MO 64116 |
| Contact | Edward I Stout |
| Correspondent | Edward I Stout SOUTHWEST TECHNOLOGIES, INC. 1746 LEVEE RD. Kansas City, MO 64116 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-08-30 |
| Decision Date | 2010-11-03 |
| Summary: | summary |