| Device Classification Name |
Detectors And Removers, Lice, (Including Combs)
|
| 510(k) Number |
K981250 |
| Device Name |
LICEMEISTER COMB |
| Applicant |
| National Pediculosis Assoc. |
| 50 Kearney Rd. |
|
Needham,
MA
02494
|
|
| Applicant Contact |
HANS SCHWARTZ |
| Correspondent |
| National Pediculosis Assoc. |
| 50 Kearney Rd. |
|
Needham,
MA
02494
|
|
| Correspondent Contact |
HANS SCHWARTZ |
| Regulation Number | 880.5960 |
| Classification Product Code |
|
| Date Received | 04/06/1998 |
| Decision Date | 05/28/1998 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|