Device Classification Name |
instrument, ent manual surgical
|
510(k) Number |
K942065 |
Device Name |
DISPOSABLE ENT PUNCH |
Applicant |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Applicant Contact |
DEBORAH ROCKAFELLOW |
Correspondent |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Correspondent Contact |
DEBORAH ROCKAFELLOW |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 04/29/1994 |
Decision Date | 06/06/1994 |
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
|
|
|