The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for China Nails And Accessories.
Device ID | K123948 |
510k Number | K123948 |
Device Name: | CHINA NAILS AND ACCESSORIES |
Classification | Nail, Fixation, Bone |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Jason Sells |
Correspondent | Jason Sells SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | JDS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-21 |
Decision Date | 2013-03-14 |
Summary: | summary |