Device Classification Name |
dissector, tonsil
|
510(k) Number |
K940903 |
Device Name |
TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES |
Applicant |
MEDICAL INSIGHTS, INC. |
193 WHITEHALL AVE. |
MYSTIC,
CT
06355
|
|
Applicant Contact |
ROBERT J CARICATO |
Correspondent |
MEDICAL INSIGHTS, INC. |
193 WHITEHALL AVE. |
MYSTIC,
CT
06355
|
|
Correspondent Contact |
ROBERT J CARICATO |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 02/24/1994 |
Decision Date | 04/14/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|