The following data is part of a premarket notification filed by Russell Samuels Orthodontic Design with the FDA for Nitom Locking Facebow.
Device ID | K052553 |
510k Number | K052553 |
Device Name: | NITOM LOCKING FACEBOW |
Classification | Headgear, Extraoral, Orthodontic |
Applicant | RUSSELL SAMUELS ORTHODONTIC DESIGN 7 CRICKET LANE LOUGHBOROUGH, Leicestershire, England, GB Le11 3pd |
Contact | Russell Henry Ashleigh Samuels |
Correspondent | Russell Henry Ashleigh Samuels RUSSELL SAMUELS ORTHODONTIC DESIGN 7 CRICKET LANE LOUGHBOROUGH, Leicestershire, England, GB Le11 3pd |
Product Code | DZB |
CFR Regulation Number | 872.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-16 |
Decision Date | 2005-12-22 |
Summary: | summary |