Device Classification Name |
stand, instrument, ac-powered, ophthalmic
|
510(k) Number |
K853358 |
Device Name |
RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM |
Applicant |
DENTSPLY INTL. |
96 CALDWELL DR. |
CINCINNATI,
OH
45216
|
|
Applicant Contact |
SEMMELMAN |
Correspondent |
DENTSPLY INTL. |
96 CALDWELL DR. |
CINCINNATI,
OH
45216
|
|
Correspondent Contact |
SEMMELMAN |
Regulation Number | 886.1860
|
Classification Product Code |
|
Date Received | 08/12/1985 |
Decision Date | 10/04/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|