The following data is part of a premarket notification filed by Blackstone & Breglio Industries with the FDA for Becsic Collar.
Device ID | K820366 |
510k Number | K820366 |
Device Name: | BECSIC COLLAR |
Classification | Orthosis, Cervical |
Applicant | BLACKSTONE & BREGLIO INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IQK |
CFR Regulation Number | 890.3490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-09 |
Decision Date | 1982-03-01 |