Device Classification Name |
microscope, operating & accessories, ac-powered, ophthalmic
|
510(k) Number |
K891001 |
Device Name |
MICROSCOPE KNOB COVER, STERILE, DISPOSABLE |
Applicant |
PRESCOTT'S, INC. |
2915 VANDENBURG AVE. |
MONUMENT,
CO
80132
|
|
Applicant Contact |
PAUL REDNER |
Correspondent |
PRESCOTT'S, INC. |
2915 VANDENBURG AVE. |
MONUMENT,
CO
80132
|
|
Correspondent Contact |
PAUL REDNER |
Regulation Number | 878.4700
|
Classification Product Code |
|
Date Received | 02/27/1989 |
Decision Date | 04/11/1989 |
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
|
|
|