| Device Classification Name |
Device, Acupressure
|
| 510(k) Number |
K110821 |
| Device Name |
BARF BAND |
| Applicant |
| Doodlebug Products, LLC |
| 5 Hemingway Ln. |
|
West Newbury,
MA
01985
|
|
| Applicant Contact |
BARRY E SANDS |
| Correspondent |
| Doodlebug Products, LLC |
| 5 Hemingway Ln. |
|
West Newbury,
MA
01985
|
|
| Correspondent Contact |
BARRY E SANDS |
| Classification Product Code |
|
| Date Received | 03/24/2011 |
| Decision Date | 02/27/2012 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Neurology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|