Device Classification Name |
Probe, Lachrymal
|
510(k) Number |
K843491 |
Device Name |
CONCEPT FIBER OPTIC CANALICULUS INTUBA |
Applicant |
CONCEPT, INC. |
12707 U.S. 19 SOUTH |
CLEARWATER,
FL
33546
|
|
Applicant Contact |
unknown unknown |
Correspondent |
CONCEPT, INC. |
12707 U.S. 19 SOUTH |
CLEARWATER,
FL
33546
|
|
Correspondent Contact |
unknown unknown |
Regulation Number | 886.4350 |
Classification Product Code |
|
Date Received | 09/06/1984 |
Decision Date | 10/05/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|