The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Sureshot Tan Nails And Accessories.
Device ID | K092748 |
510k Number | K092748 |
Device Name: | SURESHOT TAN NAILS AND ACCESSORIES |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
Contact | David Henley |
Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-08 |
Decision Date | 2010-04-26 |
Summary: | summary |