Device Classification Name |
Orthosis, Cervical
|
510(k) Number |
K820366 |
Device Name |
BECSIC COLLAR |
Applicant |
BLACKSTONE & BREGLIO INDUSTRIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BLACKSTONE & BREGLIO INDUSTRIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 890.3490 |
Classification Product Code |
|
Date Received | 02/09/1982 |
Decision Date | 03/01/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|