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 |