Device Classification Name |
Orthosis, Cranial
|
510(k) Number |
K193383 |
Device Name |
SnugKap |
Applicant |
HeadStart, Ltd. |
1550 E. Higgins Road, Suite 123 |
Elk Grove Village,
IL
60007
|
|
Applicant Contact |
James McCartney |
Correspondent |
MCRA, LLC |
1050 K Street NW, Suite 1000 |
Washington,
DC
20001
|
|
Correspondent Contact |
Dave McGurl |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 12/05/2019 |
Decision Date | 06/07/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|