Device Classification Name |
Frame, Spectacle
|
510(k) Number |
K933424 |
Device Name |
STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN |
Applicant |
ZYLOWARE CORP. |
11-36 46TH RD. |
LONG ISLAND CITY,
NY
11101
|
|
Applicant Contact |
THOMAS HECKEL |
Correspondent |
ZYLOWARE CORP. |
11-36 46TH RD. |
LONG ISLAND CITY,
NY
11101
|
|
Correspondent Contact |
THOMAS HECKEL |
Regulation Number | 886.5842
|
Classification Product Code |
|
Date Received | 07/13/1993 |
Decision Date | 09/20/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|