The following data is part of a premarket notification filed by Foothills Industries, Inc. with the FDA for Foothills Surgical Drapes.
Device ID | K041224 |
510k Number | K041224 |
Device Name: | FOOTHILLS SURGICAL DRAPES |
Classification | Drape, Surgical |
Applicant | FOOTHILLS INDUSTRIES, INC. 172 LUKIN ST. Marion, NC 28752 |
Contact | Joy Shuford |
Correspondent | Joy Shuford FOOTHILLS INDUSTRIES, INC. 172 LUKIN ST. Marion, NC 28752 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-10 |
Decision Date | 2005-02-03 |
Summary: | summary |