Device Classification Name |
knife, ophthalmic
|
510(k) Number |
K850049 |
Device Name |
KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA |
Applicant |
XTAL CORP. |
17 HILLSIDE DR. |
MALVERNE,
PA
19355
|
|
Applicant Contact |
ALAN P SCHWARTZ |
Correspondent |
XTAL CORP. |
17 HILLSIDE DR. |
MALVERNE,
PA
19355
|
|
Correspondent Contact |
ALAN P SCHWARTZ |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 01/08/1985 |
Decision Date | 03/06/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|