Device Classification Name |
microscope, operating & accessories, ac-powered, ophthalmic
|
510(k) Number |
K853855 |
Device Name |
XTAL X-150 OPERATING MICROSCOPE |
Applicant |
XTAL CORP. |
215 SOUTH HIGHWAY 101 |
STE. 200-A |
SOLANA BEACH,
CA
92075
|
|
Applicant Contact |
ALAN P SCHWARTZ |
Correspondent |
XTAL CORP. |
215 SOUTH HIGHWAY 101 |
STE. 200-A |
SOLANA BEACH,
CA
92075
|
|
Correspondent Contact |
ALAN P SCHWARTZ |
Regulation Number | 878.4700
|
Classification Product Code |
|
Date Received | 09/16/1985 |
Decision Date | 10/15/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|