The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Nasal Septal Splint.
Device ID | K952207 |
510k Number | K952207 |
Device Name: | NASAL SEPTAL SPLINT |
Classification | Splint, Intranasal Septal |
Applicant | SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
Contact | Alicia Farage |
Correspondent | Alicia Farage SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
Product Code | LYA |
CFR Regulation Number | 874.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-10 |
Decision Date | 1995-06-07 |