Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K981196 |
Device Name |
MEDITEC LINK |
Applicant |
AESCULAP-MEDITEC NORTH AMERICA |
23832 VIA MONTE |
COTO DE CAZA,
CA
92679 -4001
|
|
Applicant Contact |
WILLIAM T KELLEY |
Correspondent |
AESCULAP-MEDITEC NORTH AMERICA |
23832 VIA MONTE |
COTO DE CAZA,
CA
92679 -4001
|
|
Correspondent Contact |
WILLIAM T KELLEY |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 03/19/1998 |
Decision Date | 06/17/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|