Device Classification Name |
Pump, Infusion
|
510(k) Number |
K890783 |
Device Name |
GRIESHABER VISCOELASTIC INJECTION SYSTEM |
Applicant |
GRIESHABER & CO. |
3000 CABOT BLVD. WEST |
P.O. BOX 1099 |
LANGHORNE,
PA
19047
|
|
Applicant Contact |
JOHN E RICHMOND |
Correspondent |
GRIESHABER & CO. |
3000 CABOT BLVD. WEST |
P.O. BOX 1099 |
LANGHORNE,
PA
19047
|
|
Correspondent Contact |
JOHN E RICHMOND |
Regulation Number | 880.5725 |
Classification Product Code |
|
Date Received | 02/15/1989 |
Decision Date | 05/16/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|