The following data is part of a premarket notification filed by Glenroe Technologies with the FDA for Glenroe Plastic Bracket.
Device ID | K932920 |
510k Number | K932920 |
Device Name: | GLENROE PLASTIC BRACKET |
Classification | Bracket, Plastic, Orthodontic |
Applicant | GLENROE TECHNOLOGIES 1912 44TH AVE., EAST Bradenton, FL 34203 |
Contact | John F Bozman |
Correspondent | John F Bozman GLENROE TECHNOLOGIES 1912 44TH AVE., EAST Bradenton, FL 34203 |
Product Code | DYW |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-15 |
Decision Date | 1993-08-24 |