The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Turbinate Nasal Splint.
Device ID | K921202 |
510k Number | K921202 |
Device Name: | TURBINATE NASAL SPLINT |
Classification | Splint, Intranasal Septal |
Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Thomas Craig |
Correspondent | Thomas Craig SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | LYA |
CFR Regulation Number | 874.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-12 |
Decision Date | 1992-07-23 |