Device Classification Name |
lens, contact, polymethylmethacrylate, diagnostic
|
510(k) Number |
K023221 |
Device Name |
CONTACT LASER & DIAGNOSTIC LENSES |
Applicant |
VOLK OPTICAL, INC. |
15825 SHADY GROVE RD. |
SUITE 30 |
ROCKVILLE,
MD
20850
|
|
Applicant Contact |
RICHARD E LIPPMAN |
Correspondent |
VOLK OPTICAL, INC. |
15825 SHADY GROVE RD. |
SUITE 30 |
ROCKVILLE,
MD
20850
|
|
Correspondent Contact |
RICHARD E LIPPMAN |
Regulation Number | 886.1385
|
Classification Product Code |
|
Date Received | 09/27/2002 |
Decision Date | 10/11/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|