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
|
|
|